About the TWINPEAK Study
Trial Name: 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
ClinicalTrials.gov Identifier: NCT05482893
Sponsor: Phanes Therapeutics
Recruitment Contact: Phanes Therapeutics, 858-766-0852, clinical-trials@phanestx.com
Completion Date: April 20276
The first patient has been dosed in the TWINPEAK clinical trial (NCT05482893) evaluating the combination of PT886 and pembrolizumab (Keytruda) for the potential treatment of gastric and gastroesophageal junction (GEJ) cancers.1
PT886 is a bispecific antibody designed to target 2 proteins, claudin 18.2 and CD47, both of which are overexpressed in certain tumor cells. By simultaneously targeting both proteins, PT886 is expected to enhance the immune system’s ability to recognize and destroy cancer cells by channeling them into phagocytic antigen-presenting cells.
The drug has been granted orphan drug designation (ODD) by the FDA for the treatment of pancreatic cancer and, more recently, received fast track designation in metastatic claudin 18.2-positive pancreatic adenocarcinoma.
About the TWINPEAK Study
The TWINPEAK study is a multicenter, open-label, phase 1/2 trial evaluating PT886 both as a monotherapy and in combination with pembrolizumab or chemotherapy.2 The study is assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the agent in patients with locally advanced or metastatic gastric, GEJ, and pancreatic cancers.
Eligible patients must have histologically or cytologically confirmed diagnoses of advanced disease that has progressed after standard therapies or where such therapies are deemed ineffective or inappropriate. Other inclusion criteria include measurable disease, at least 1 lesion evaluable according to RECIST 1.1 criteria, and adequate organ function, with an ECOG performance status of 0 or 1.
The phase 1 portion of the study employs a 3+3 dose-escalation design, starting with 0.1 mg/kg of PT886 administered weekly. Additional dose levels under evaluation include 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 6 mg/kg weekly. In the dose-expansion phase, 2 doses—likely the maximum tolerated dose (MTD) and a lower dose—will be selected for further study.
Primary end points being evaluated in the trial include dose-limiting toxicities, MTD, the recommended phase 2 dose, and safety and tolerability of PT886. Preliminary efficacy, measured by the objective response rate, is a key secondary end point being explored in the study. Other secondary end points include pharmacokinetics and immunogenicity.
In addition to the US-based TWINPEAK study, a parallel phase 1 trial of PT886 is ongoing in China (CTR20241655).1
REFERENCES:
Phanes Therapeutics announces first patient dosed in clinical study of PT886 in combination with KEYTRUDA® (pembrolizumab). News release. Phanes Therapeutics, Inc. October 8, 2024. Accessed October 9, 2024. https://tinyurl.com/ms3hk88v
PT886 for treatment of patients with advanced gastric, gastroesophageal junction and pancreatic adenocarcinoma. ClinicalTrials.gov. Updated August 9, 2024. Accessed October 9, 2024. https://www.clinicaltrials.gov/ct2/show/NCT05482893
