S825 EVALUATION OF AMG 420, AN ANTI-BCMA BISPECIFIC T-CELL ENGAGER (BITE®) IMMUNOTHERAPY, IN R/R MULTIPLE MYELOMA (MM) PATIENTS: UPDATED RESULTS OF A FIRST-IN-HUMAN (FIH) PHASE 1 DOSE ESCALATION STUDY

Abstract Background: CP-751,871, a fully human IgG2 subtype monoclonal antibody, is a potent and specific inhibitor of the insulin- like growth factor type I receptor (IGF-IR). The IGF-IR regulates the growth, survival, adhesion and invasiveness of multiple myeloma cells. High IGF-IR expression is observed in poor-prognostic subtypes of multiple myeloma and its inhibition has been long proposed as a potential therapeutic approach for treatment of this disease. Methods: A phase 1 dose escalation study was conducted to define the safety and tolerability, and to characterize the pharmacokinetic and pharmacodynamic (granulocyte surface IGF-IR expression and serum IGF-I levels) properties of CP-751,871 in patients with multiple myeloma. Patient’s eligibility included previously treated multiple myeloma in relapse or refractory phase including those less than complete remission to autologous stem cell transplant or tandem transplant. Results: Following informed consent and screening, 47 patients were enrolled into 11 dose-escalation cohorts of CP-751,871 at doses from 0.025 to 20 mg/Kg. Median patient age was 60 years. Median number of previous regimens was 4 (range 1–8). CP-751,871 was given as an IV infusion on Day 1 of 4-week cycles. Patients with a suboptimal response to CP-751,871 alone were eligible to receive CP-751,871 in combination with either oral dexamethasone and/or rapamycin at the discretion of the investigator. Twenty-seven patients received CP-751, 871 in combination with dexamethasone, while four patients received rapamycin in combination with either CP-751,871 or CP-751,871 and dexamethasone. Median number of treatment cycles was 3 (range 1–16). Ten patients were dosed at the highest cohort of 20 mg/Kg. No CP-751,871 related dose limiting toxicities were identified. Grade 3 toxicities were all observed at the 20 mg/Kg cohort (1 hyperglycemia, 1 anemia, 1 AST increase, 1 accidental fall, 1 muscle weakness). Plasma CP-751,871 exposure increased with dose, and the pharmacokinetic characteristics were consistent with target-mediated disposition. Granulocyte IGF-IR expression was maximally down-regulated for the entire duration of the dosing period at doses ≥1.5 mg/kg, indicating a saturation of circulating targets. CP-751,871 also led to a dose-dependent increase in circulating IGF-I concentrations. Tumor response was assessed according to Blade criteria. Two remissions and 4 partial remissions were reported in patients treated with different doses of CP-751,871 in combination with dexamethasone. Interestingly, the 2 patients with remission were previously found to be refractory to dexamethasone treatment. Conclusions: These data indicate that CP-751,871 is well tolerated either as a single agent or in combination with dexamethasone. Furthermore, CP-751,981 in combination with dexamethasone, may constitute a novel and effective therapeutic approach for patients with multiple myeloma.

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Phase 1 dose escalation study of MEDI-565, a bispecific T-cell engager that targets human carcinoembryonic antigen (CEA), in patients with advanced gastrointestinal (GI) adenocarcinomas.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.4_suppl.320 ◽

2016 ◽

Vol 34 (4_suppl) ◽

pp. 320-320

Author(s):

Michael J. Pishvaian ◽

Michael Morse ◽

Jennifer T. McDevitt ◽

Song Ren ◽

Gabriel Robbie ◽

...

Keyword(s):

T Cell ◽

Antitumor Activity ◽

Dose Escalation ◽

Half Life ◽

High Titer ◽

Phase 1 ◽

Single Chain ◽

Dose Escalation Study ◽

Human T Cell ◽

Grade 3

320 Background: MEDI-565, a bispecific single-chain antibody, targets human CEA on tumor cells and the CD3 epsilon subunit of the human T-cell receptor complex. In murine models, MEDI-565 showed antitumor activity in CEA-expressing tumors (J Immunother 2009;34:341-52). Methods: This phase 1, multicenter, open-label, dose-escalation study enrolled adults with GI adenocarcinomas (including esophageal, gastric, small intestine, colorectal, biliary tract, and pancreatic). MEDI-565 was given intravenously over 3 h on days 1–5 in 28-day cycles, with 4 single-patient (pt) (0.75–20 μg) and 5 standard 3+3 escalation (60 μg–3 mg; 1.5–7.5 mg with dexamethasone [dex]) cohorts. Primary objective was to determine the maximum tolerated dose (MTD); secondary objectives were to evaluate pharmacokinetics (PK), antidrug antibody (ADA), and antitumor activity. Results: Study enrolled39 pts: mean age 59 y; 56% male; 28 (72%) colorectal, 6 (15%) pancreatic, 5 (13%) other. Dose-limiting toxicities (grade ≥ 3 nonhematologic) were seen in 4 pts (2 at 3-mg; 2 at 7.5-mg + dex): hypoxia (n = 2), diarrhea, and cytokine release syndrome (CRS). Grade 3 treatment-related adverse events (AEs) seen in 5 pts: diarrhea, CRS, increased alanine aminotransferase, hypertension (all n = 1), and hypoxia (n = 2). Treatment-related serious AEs seen in 6 pts: diarrhea, vomiting, pyrexia, CRS (all n = 1), and hypoxia (n = 2). Five pts discontinued treatment due to AEs: diarrhea, CRS, central nervous system metastases, and hypoxia (n = 2). MEDI-565 exposures increased in approximately dose-proportional manner, with clearance (35–77 L/d) and half-life (2–7 h) typical of drug class. ADA had minor impact; 19 pts (48.7%) had ADAs, 5/39 (12.8%) with high titer, with decreased MEDI-565 concentrations in 2 pts. Plasma inflammatory cytokines were elevated posttreatment in several pts at 1.5- and 3-mg (no dex) dose levels. No objective responses were observed; 11 (28%) pts had stable disease as best response. Conclusions: The MTD of MEDI-565 in pts with GI adenocarcinomas was 5 mg with dex. PK was linear, with fast clearance and short half-life. No objective responses were observed. Clinical trial information: NCT01284231.

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Phase 1/2 dose-escalation study of marizomib (MRZ, NPI-0052) plus low dose dexamethasone (DEX) in patients with relapsed and refractory multiple myeloma; study NPI-0052-101 (NCT00461045)

Clinical Lymphoma Myeloma & Leukemia ◽

10.1016/j.clml.2015.07.567 ◽

2015 ◽

Vol 15 ◽

pp. e271-e272

Author(s):

P. Richardson ◽

T. Zimmerman ◽

C. Hofmeister ◽

M. Talpaz ◽

A. Chanan Khan ◽

...

Keyword(s):

Multiple Myeloma ◽

Dose Escalation ◽

Low Dose ◽

Phase 1 ◽

Dose Escalation Study ◽

Refractory Multiple Myeloma

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MM-004: A Phase 1, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, Efficacy, and Pharmacokinetics of Pomalidomide Alone or in Combination with Dexamethasone in Patients with Refractory or Relapsed and Refractory Multiple Myeloma in Japan

Blood ◽

10.1182/blood.v124.21.2107.2107 ◽

2014 ◽

Vol 124 (21) ◽

pp. 2107-2107

Author(s):

Shinsuke Iida ◽

Hiromi Iwasaki ◽

Takaaki Chou ◽

Kensei Tobonai ◽

Kazutaka Sunami ◽

...

Keyword(s):

Multiple Myeloma ◽

Single Dose ◽

Plasma Concentration ◽

Dose Escalation ◽

Research Funding ◽

Phase 1 ◽

Dose Escalation Study ◽

Refractory Multiple Myeloma ◽

Multiple Doses ◽

Dose Levels

Abstract Background: Patients (pts) with refractory or relapsed and refractory multiple myeloma (RRMM) who have exhausted treatment (Tx) with lenalidomide (LEN) or thalidomide (THAL) and bortezomib (BORT) have shortened overall survival (OS; Kumar, Leukemia, 2012). Pomalidomide (POM) is a novel oral IMiDs® immunomodulatory agent with direct antimyeloma and stromal cell inhibitory effects (Quach, Leukemia, 2010; Mark, Leuk Res, 2014). POM 4 mg (± dexamethasone) is approved in some countries for Tx of pts with RRMM based on phase 3 results showing significant improvement vs high-dose dexamethasone in response, progression-free survival (PFS), and OS and phase 1/2 results showing high and durable overall response rates (ORRs; Richardson, Blood, 2013; Richardson, Blood, 2014; San Miguel, Lancet Oncol, 2013). MM-004 is a phase 1, open-label, dose-escalation study designed to assess the tolerated dose (TD), safety, efficacy, and pharmacokinetics (PK) of POM alone or POM + low-dose dexamethasone (LoDEX) in Japanese pts with RRMM. Methods: Pts must have been ≥ 20 yrs old with a documented diagnosis of MM, have had ≥ 2 prior lines of anti-MM Tx including ≥ 2 cycles of LEN and BORT (alone or in combination), and have RRMM defined as progressive disease (PD) during or within 60 days of completing their last anti-MM Tx. Tx consisted of POM 2 mg (Cohort 1) or 4 mg (Cohort 2) day (D) 1-21 of a 28-D cycle and DEX 40 mg (20 mg for pts > 75 yrs) D1, 8, 15, and 22 (starting on cycle 2). Tx was continued until PD, unacceptable adverse event (AE), or voluntary withdrawal. Pts enrolled in Cohort 1 received a single dose of POM 0.5 mg at D7 for PK evaluation. The primary endpoint was TD; secondary endpoints included ORR based on International Myeloma Working Group criteria, objective response, duration of response (DOR), PFS, PK, and safety. Results: Twelve pts were enrolled (6 in each cohort); 2 pts remain on Tx as of June 27, 2014 (Cohort 2, n= 2). Median age was 68 yrs (range, 52-76 yrs); 75% of pts were aged > 65 yrs. Median number of prior anti-MM Tx was 6 (range, 4-10) and baseline creatinine clearance (CrCl) was ≥ 60 mL/min for all pts except one. Six pts received prior THAL-based Tx (Cohort 1, n= 3; Cohort 2, n= 3). TD was determined to be POM 4 mg D1-21 of a 28-D cycle (a dose-limiting toxicity of grade 4 neutropenia for ≥ 7 days was observed in 1 pt in cohort 1). This result showed that the TD of POM in Japanese pts with MM was the same as that in Caucasian pts with MM. Median duration of treatment was 6.5 cycles in all pts. The best ORR (≥ partial response [PR]) was 25% (3/12 pts) across both cohorts; ORR was 17% (1/6) in Cohort 1 and 33% (2/6) in Cohort 2. Overall median PFS was 5.5 months (5.1 months in Cohort 1; not reached in Cohort 2). Maximum POM plasma concentration (Cmax) was 9.1, 35.6, and 70.2 ng/mL after single dose of POM 0.5, 2, and 4 mg, respectively, and was reached at times ranging from 0.9 to 6 h. Cmax was 37.6 and 71.2 ng/mL after multiple doses of POM 2 and 4 mg. Systemic POM exposure as measured by geometric means of area under the plasma concentration time curve (AUC) was 84.9, 364.4, and 685.7 ng•h /mL after a single doses of POM 0.5, 2, and 4 mg, respectively. AUC was 411.5 and 713.8 ng•h /mL after multiple doses of POM 2 mg and 4 mg. Both Cmax and AUC exposures increased in a dose-proportional manner from 0.5 to 4 mg, as assessed by both visual inspection and statistical analysis. Clearance and volume of distribution were similar across dose levels. The mean half-life (t1/2) of POM was comparable across dose levels, with t1/2 of approximately 6.4, 6.9, and 6 h after single doses of POM 0.5, 2, and 4 mg, respectively. After multiple doses of POM 2 mg and 4 mg, t1/2was approximately 7.3 and 5.5 h. Grade ≥ 3 AEs occurred in 11 pts (92%), and the most frequently reported AE was neutropenia (8 pts, 67%). Other frequently reported AEs (all grades) were thrombocytopenia, anemia, leukopenia, and peripheral edema. Conclusions: POM 4 mg was identified as the TD in Japanese pts with RRMM, which is consistent with previous findings in Caucasian pts with MM. However, pts should be monitored for the known AE profile of POM and managed appropriately. The combination of POM with LoDEX was also found to be tolerable in Japanese pts with RRMM. Systemic exposure to POM increased dose proportionally, and limited drug accumulation was observed following multiple doses. Responses (≥ PR) were observed in 25% of pts. Further investigation of the efficacy and safety of POM + LoDEX in Japanese pts with RRMM in a phase 2 trial is warranted. Disclosures Iida: Celgene Corp: Honoraria, Research Funding. Tobonai:Ono: Research Funding; Lilly: Research Funding; Janssen: Research Funding; Celgene Corporation: Research Funding. Sunami:Celgene Corp: Honoraria. Kurihara:Celgene Corporation: Employment. Midorikawa:Celgene: Employment. Zaki:Celgene : Employment, Equity Ownership. Doerr:Celgene Corp: Employment.

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Pralatrexate in Combination with Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Previously Untreated Patients with Peripheral T-Cell Lymphoma (PTCL): A Phase 1 Dose-Escalation Study

Blood ◽

10.1182/blood.v130.suppl_1.818.818 ◽

2017 ◽

Vol 130 (Suppl_1) ◽

pp. 818-818 ◽

Cited By ~ 1

Author(s):

Andrei Shustov ◽

Patrick B Johnston ◽

Stefan Klaus Barta ◽

Gajanan Bhat ◽

Guru Reddy ◽

...

Keyword(s):

T Cell ◽

Dose Escalation ◽

Cell Lymphoma ◽

Phase 1 ◽

T Cell Lymphoma ◽

Peripheral T Cell Lymphoma ◽

Dose Escalation Study ◽

Chop Regimen ◽

Treatment Naïve ◽

Grade 3

Abstract Background: The prognosis of patients with PTCL remains poor after standard CHOP therapy - the most commonly used combination regimen. Relapses occur in the majority of patients, and curability rates of the relapsed disease are very low. Hence, advances in front-line therapy of PTCL are long overdue. Pralatrexate, a second-generation antifolate, demonstrated a single agent activity in patients with relapsed and refractory PTCL with a response rate of 27%, including complete remissions in 11% of patients (O'Connor et al. J Clin Onc 2011). We conducted a Phase 1 multi-center dose-escalation study of pralatrexate in combination with standard CHOP (Fol-CHOP) in treatment-naïve PTCL patients. Objectives: The primary objective of the study was to determine the maximum tolerated dose (MTD) of pralatrexate when administered with a standard CHOP regimen to patients with newly diagnosed PTCL. The secondary objectives included safety, tolerability, efficacy and pharmacokinetics of pralatrexate in combination with CHOP (Fol-CHOP). Methods: In Part 1 of this 3+3 dose-escalation study, pralatrexate was administered at 10, 15, 20, 25, or 30 mg/m2 as an IV push on days 1 and 8 of a standard 21-day CHOP regimen (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 [maximum 2 mg] on day 1 and oral prednisone 100 mg on days 1-5). In Part 2 of the study patients were treated at the MTD of pralatrexate established in Part 1, with standard CHOP. In both parts of the study patients were treated with up to 6 cycles of therapy, or until toxicity or disease progression. Patients received antimicrobial prophylaxis, myeloid growth factor support, and "leucovorin rescue" throughout 6 cycles of therapy. Dose-limiting toxicities (DLT) were considered during the 1st cycle of Fol-CHOP and included: Grade 4 infections, treatment-related non-hematological toxicity ≥Grade 3, platelet count < 25 X 109/L at any time, or ANC < 0.5 X 109/L for >7 days despite G-CSF administration. Responses were assessed by the investigator per the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). Results: A total of 31 patients have been enrolled (19 in Part 1; 12 in Part 2). MTD was not reached and pralatrexate dose of 30 mg/m2 in combination with CHOP was selected for Part 2 of the study as predefined by the protocol. The majority of patients were male, White, with the median age of 66 yrs (range, 18-78) at the time of enrolment. PTCL diagnoses included: anaplastic large cell lymphoma, anaplastic lymphomakinase-negative (ALCL, ALK-, n=5), peripheral T-cell lymphoma, not-otherwise specified (PTCL-NOS, n=18), and angioimmunoblastic T-cell lymphoma (AITL, n=5). Fol-CHOP was generally well tolerated with median RDI of 98%. Common (≥ 30%) adverse events (AEs) of any grade were fatigue (n=23), constipation (n=20), nausea (n=16), mucositis (n=14), diarrhea (n=12), anemia (n=9), vomiting (n=10) and oral pain (n=10). Most common (≥ 10%) AEs ≥ grade 3 were anemia (n=6), fatigue (n=4) and neutrophil count decreas (n=5). The only Grade >3 treatment-related AEs (≥10%) was neutrophil count decrease (n=4). SAEs were observed in 13 patients, treatment related SAEs were anemia, febrile neutropenia, dehydration, mucositis and nausea. Five patients withdrew from study: 2 due to disease progression, 1 due to AE and 2 due lapse >28 days between doses. In the 27 patients avaluable for response, the investigator assessed objective response (OR) and complete response (CR) rates were 89% wand 67%, respectively. Conclusions: The combination of pralatrexate and CHOP was well tolerated in treatment-naive PTCL patients. MTD of pralatrexate was not reached, and the protocol-defined maximum dose of 30 mg/m2 on days 1 and 8 of a 21-day CHOP cycle was recomended for future studies. The observed OR and CR rates warrant further evaluation of this regimen in newly diagnosed PTCL patients. Disclosures Shustov: Celgene: Other: Publication assistance; Spectrum Pharmaceuticals: Consultancy, Research Funding. Bhat: Spectrum Pharmaceuticals: Employment. Reddy: Spectrum Pharmaceuticals: Employment.

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Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide-3-kinase-δ,γ, in patients with relapsed/refractory lymphoma.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.8518 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 8518-8518 ◽

Cited By ~ 17

Author(s):

Steven M. Horwitz ◽

Ian Flinn ◽

Manish R. Patel ◽

Anas Younes ◽

Francine M. Foss ◽

...

Keyword(s):

T Cell ◽

Dose Escalation ◽

Phase 1 ◽

Single Agent ◽

Clinical Activity ◽

Dose Escalation Study ◽

Safety And Efficacy ◽

Early Results ◽

Refractory Lymphoma ◽

Grade 3

8518 Background: Phosphoinositide-3-kinases (PI3Ks) are pivotal in cell signaling and regulate a variety of cellular functions relevant to oncogenesis. IPI-145, a potent oral inhibitor of the PI3KEδ and PI3K-γ isoforms, is in clinical development for patients (pts) with hematologic malignancies. Early results in pts with relapsed/refractory lymphoma from an ongoing Phase 1 study are reported here. Methods: This dose-escalation study evaluates the safety, maximum tolerated dose (MTD), clinical activity, and pharmacokinetics (PK) of IPI-145. Expansion cohorts (EC) < MTD are allowed. IPI-145 is given orally twice daily (BID) in 28-day cycles. Tumor response is based on standard disease-specific criteria. Results: 55 pts have been dosed with IPI-145. PK, available through 50 mg BID, are linear with complete inhibition of PI3K-δ at doses > 15 mg BID and increasing suppression of PI3K-γ with increasing dose. In the 36 pts with lymphoma who received 15 mg to 75 mg BID, the median [range] number of cycles was 2.4 [0.1–10] and 67% remain on study. Treatment-related adverse events (TRAEs) occurred in 50% of pts with lymphoma. Neutropenia and increased ALT were the most common ≥ Grade 3 TRAEs (4 pts each) and were not associated with increasing dose. > Grade 3 ALT elevations were more common in lymphoma pts (18%) compared to non-lymphoma pts (5%). Among evaluable pts with lymphoma (n=27), early clinical activity was observed in T-cell (n=6, 1 CR, 1 PR, 1 SD) and aggressive/indolent B-cell (n=21, 2 CR, 9 PR, 5 SD) lymphoma pts at ≤ 75 mg BID. 92% of responses were observed by 3 months. Conclusions: IPI-145 appeared well tolerated and has shown clinical activity in pts with relapsed/refractory advanced B- and T-cell lymphoma across the range of doses examined. The single agent MTD has not been determined and dose escalation continues. Updated safety and efficacy data from pts with lymphoma enrolled in dose escalation or ECs evaluating 25 mg BID and a higher dose (< MTD) of IPI-145 will be presented. Clinical trial information: NCT01476657.

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HPN217-3001: A Phase 1/2 Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217, a Bcma-Targeting T-Cell Engager, in Patients with Relapsed/Refractory Multiple Myeloma

Blood ◽

10.1182/blood-2020-136012 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 10-10

Author(s):

Henning Schade ◽

Sumit Madan ◽

Eva Medvedova ◽

Rajneesh Nath ◽

Lisa Knapp ◽

...

Keyword(s):

Multiple Myeloma ◽

T Cell ◽

T Cell Activation ◽

Dose Escalation ◽

Cell Activation ◽

Ad Hoc ◽

Phase 1 ◽

Advisory Board ◽

Publicly Traded ◽

Open Label

Background B cell maturation antigen (BCMA) has emerged as a promising target for multiple myeloma (MM) therapies based on its restricted expression profile and functional role in promoting MM cell survival. Some of these BCMA targeting molecules, including CAR-T cells and CD3-based T cell engaging molecules, have demonstrated efficacy against relapsed/refractory MM (R/R MM) in clinical trials. HPN217 is a BCMA -targeting T cell engager with Harpoon's proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, a recombinant polypeptide of ~50kDa containing three humanized antibody-derived binding domains, targeting BCMA (for tumor binding), albumin (for half-life extension) and CD3 (for T cell engagement). It has been engineered to be a small, globular protein to enable efficient exposure in tumor tissue with prolonged half-life and excellent stability under physiological conditions. HPN217 mediates potent target tumor cell killing in a BCMA-specific manner in vitro and in xenograft models in the presence of T cells. Consistent with its mechanism of action (MOA), tumor cell killing is accompanied by T cell activation, cytokine induction, and T cell expansion. HPN217 binds monomerically to CD3 and BCMA, minimizing non-specific T-cell activation. Study Design and Methods HPN217-3001 is an ongoing Phase 1/2, open-label, multicenter, global study of the safety, tolerability, and pharmacokinetics of HPN217 in patients with relapsed and refractory multiple myeloma. The study is divided into 2 parts: Dose Escalation (Part 1) and Expansion (Part 2). Part 1 of the study will determine the Maximum Tolerated Dose (MTD) or the recommended Phase 2 dose (RP2D); Part 2 of the trial will evaluate the safety and efficacy of HPN217 at MTD/RP2D in patients with R/R MM. Patients, who have received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody each) and are not candidates for or intolerant to all therapies known to provide clinical benefit in MM, are eligible for enrollment. Prior exposure to a BCMA-targeting agent is permitted in Part 1 but not in Part 2. HPN217 is administered once weekly via IV infusion on Days 1, 8 and 15 during each 21-day cycle at a flat dose. Dose escalation is being performed in serial patient cohorts starting with single patient dose cohorts followed by a conventional 3 + 3 design. Intra-patient dose escalation is permitted. Dose expansion will be initiated once the MTD or a RP2D is established based on safety, preliminary efficacy, PK, and pharmacodynamic data from dose escalation, with a Simon 2-stage design to assess preliminary clinical efficacy of HPN217. Patients may continue weekly HPN217 treatment until disease progression. Primary study endpoints include frequency and severity of treatment-emergent AEs (TEAEs) graded according to NCI CTCAE version 5.0, number and severity of dose limiting toxicities (DLTs) following treatment with HPN217, and PK parameters of HPN217. The study will also evaluate overall response rate (ORR) based on IMWG response criteria, progression-free survival (PFS) and overall survival (OS), duration of response (DOR), immunogenicity of HPN217, and other exploratory endpoints related to the mechanism of action of HPN217. (NCT04184050) Disclosures Madan: Sanofi: Other: Ad hoc advisory board; GSK: Other: Ad hoc advisory board, Speakers Bureau; Karopharm: Speakers Bureau; Amgen: Other: Ad hoc advisory board, Speakers Bureau; Janssen: Other: Ad hoc advisory board, Speakers Bureau; Takeda: Other: Ad hoc advisory board, Speakers Bureau; Celgene/BMS: Other: Ad hoc advisory board, Speakers Bureau. Nath:Harpoon Therapeutics: Consultancy. Knapp:Harpoon Therapeutics: Current Employment, Current equity holder in publicly-traded company. Lemon:Harpoon Therapeutics: Current Employment, Current equity holder in publicly-traded company. Sun:Harpoon Therapeutics: Current Employment, Current equity holder in publicly-traded company.

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