Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Leucovorin

Fluorouracil

Antibodies

Capecitabine

Immune Checkpoint Inhibitors

Antibodies, Bispecific

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

An accelerated titration design will be employed, and 1 patient will be enrolled initially at each of the lower dose levels: 0.1 mg/kg, 0.3 mg/kg and 1 mg/kg. At Dose Level 4 (3 mg/kg), the standard 3+3 design will be implemented.

Two dose levels will be explored with at least 10 patients in each; the recommended dose for expansion (RDE) from Part A, and another dose level. The RDE may be the MTD or a lower dose level. Additional dose levels and regiments such as, Q2W and/or Q3W dose evaluations may be performed.

Part C, Cohort 1: Patients with m/a GC/GEJ-C, that have progressed under first line (1L) SOC chemotherapy +/- ICI, and are treatment naïve to CLDN18.2 targeting agents and are eligible for second line (2L) treatment. Patients will receive PT886 in combination with Paclitaxel.

Part C, Cohort 2: Patients with m/a PDAC that are treatment naïve for their 1L treatment. Patients will receive PT886 in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).

Patients enrolled in Part C and D of the study must present with ≥ 10% CLDN18.2 positive TC in their tumors.

Part D, Cohort 3: Patients with m/a GC/GEJ-C who have progressed under 1L or 2L SOC chemotherapy +/- ICI and are treatment naïve to CLDN18.2 targeting agents. Patients will receive PT886 in combination with KEYTRUDA® (pembrolizumab).

Part D, Cohort 4: 1L treatment of patients with HER2 negative m/a GC/GEJ-C, that are treatment naïve to CLDN18.2 targeting agents. Patients will receive PT886 in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).

Part D, Cohort 5: Patients with m/a GC/GEJ-C, that have progressed under 1L SOC chemotherapy, and zolbetuximab, and are treatment naïve to KEYTRUDA® (pembrolizumab) or other ICI therapy for their m/a disease. Patients will receive PT886 in combination with KEYTRUDA® (pembrolizumab).

Patients enrolled in Part C and D of the study must present with ≥ 10% CLDN18.2 positive TC in their tumors.

PT886 monotherapy, a novel bispecific antibody that targets Claudin 18.2 and CD47.

PT886

Chemotherapy as a combination partner to PT886 in Part C: Cohort 1

Chemotherapy as a combination partner to Abraxane and PT886 in Part C: Cohort 2

Chemotherapy as a combination partner to Gemcitabine and PT886 in Part C: Cohort 2

Abraxane

Immune checkpoint inhibitor as a combination partner to PT886 in Part D: Cohort 3, 4, and 5.

KEYTRUDA® (pembrolizumab)

Chemotherapy as a combination partner to KEYTRUDA® (pembrolizumab) and PT886 in Part D: Cohort 4

Phanes Therapeutics

Jason Henry, MD

Harshabad Singh, MD

Michael Overman, MD

Z. Esra Cobanoglu, MD

Blake Patterson

Alexander Spira, MD, PhD, FACP

This is a first-in-human, Phase 1/2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886.

Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC).

PT886 For Treatment of Patients With Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study)

A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction (GEJ), or Pancreatic Ductal AdEnocarcinomas of PT886, in Combination With Either ChemotherApy, and/or the ChecKpoint Inhibitor Pembrolizumab TWINPEAK Study

Monitor grade 3 and higher related adverse events.

Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for PT886 For Treatment of Patients With Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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