Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subject… (NCT04344795) | Clinical Trial Compass
CompletedPhase 1
Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors
United States89 participantsStarted 2020-05-06
Plain-language summary
This is a first-in-human Phase 1a/1b, multicenter, open-label, dose-escalation, dose and schedule optimization, and expansion study of TPST-1495 as a single agent and in combination with pembrolizumab to determine its maximum tolerated dose (MTD) and or recommended Phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity in subjects with advanced solid tumors. Subjects with all histologic types of solid tumors are eligible for the escalation and dose-finding portions of the study. However, the preferred tumor types for enrollment are colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial cancer, endometrial cancer, and gastroesophageal junction (GEJ) or gastric adenocarcinoma. Enrollment in the expansion cohorts is limited to the following tumor types: endometrial, SCCHN, CRC, and a basket cohort in subjects selected for an activating mutation in PIK3Ca.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must have a histologically-confirmed malignancy that is metastatic or unresectable for which there is no remaining standard therapy known to confer clinical benefit. While all solid tumor types are eligible for the dose-escalation and dose-finding portions of the study, there is a preference to enroll patients with colorectal cancer, squamous cell carcinoma of the head and neck, urothelial cancer, endometrial cancer, NSCLC, and gastric or gastroesophageal junction adenocarcinoma. The expansion cohorts are limited to the following tumor types: endometrial, SCCHN, CRC, and tumors with an activating mutation in PIK3Ca.
✓. Subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI.
✓. Eastern Cooperative Oncology Group performance status of 0 or 1 at treatment initiation.
✓. Life expectancy estimated to be ≥ 12 weeks
✓. Adequate organ and marrow function (subjects must not have received transfusions or growth factor support within 1 month prior to first dose of investigational product) as defined below:
Exclusion criteria
✕. Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study, a specimen-collection study or the follow-up period of an interventional study.
What they're measuring
1
Determination of maximum tolerated dose and/or recommended Phase 2 dose (RP2D) and optimum dose schedule for TPST-1495 as a single agent and in combination with pembrolizumab
Timeframe: From start of treatment to treatment termination visit, up to 24 months
✕. Received more than 4 doses of nonsteroidal anti-inflammatory drugs or COX-2 inhibitors within 2 weeks prior to study treatment initiation.
✕. History of allergy or hypersensitivity, GI bleed, or ulceration secondary to nonsteroidal anti-inflammatory drugs or COX-2 inhibitors.
✕. History of GI ulcer within 1 year of treatment initiation or history of untreated helicobacter pylori infection. Subjects with history of treated helicobacter pylori infection with confirmation of eradication are eligible
✕. History of diverticulitis or any GI bleed within 2 years of treatment initiation.
✕. Receipt of any anticancer therapy within the following windows:
✕. Subjects with active or untreated central nervous system (CNS) metastases
✕. New York Heart Association Classification II, III or IV.