Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Cancer

Conditions

• Colorectal Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma
• Recurrent Colorectal Carcinoma
• Recurrent Pancreatic Carcinoma
• Stage III Colorectal Cancer
• Stage III Pancreatic Cancer
• Stage IIIA Colorectal Cancer
• Stage IIIB Colorectal Cancer
• Stage IV Colorectal Cancer
• Stage IV Pancreatic Cancer
• Stage IVA Colorectal Cancer
• Stage IVA Pancreatic Cancer
• Stage IVB Colorectal Cancer
• Stage IVB Pancreatic Cancer
• Unresectable Pancreatic Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• XL888 — DRUG
  Given PO
• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

This phase Ib trial studies the side effects and best dose of Hsp90 inhibitor XL888 when given together with pembrolizumab in treating patients with advanced gastrointestinal cancer that has spread to other places in the body. XL888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving XL888 with pembrolizumab may work better in treating patients with gastrointestinal cancer.

Key Dates

Start date

Jul 7, 2017

Status verified

Aug 2025

Primary completion

Jun 10, 2021

Completion

Jun 10, 2021

Study Design

Enrollment

47 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation
  In the dose escalation phase, the trial will be open for patients with stage IV or locally advanced unresectable gastrointestinal adenocarcinomas (gastric, GEJ, cholangiocarcinoma, hepatocellular, pancreas, small intestinal tumors) who have failed at least one prior therapy. Patients with colorectal cancer must have previously received oxaliplatin, irinotecan, and a fluoropyrimidine. Patients receive pembrolizumab IV over 30 minutes on day 1 and XL888 PO on days 1, 4, 8, 11, 15, and 18. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Dose Expansion Pancreatic Cancer (Arm A)
  In the dose expansion phase, Arm A will be open for 16 patients with pancreatic adenocarcinoma. Patients must have histologic diagnosis and either locally advanced unresectable or metastatic disease that has failed at least one standard regimen. Eight patients will participate in the paired biopsy studies. Patient selected for biopsy must have a primary or metastatic non-bone site that is amenable to safe biopsy. Patients receive pembrolizumab IV over 30 minutes on day 1 and XL888 PO on days 1, 4, 8, 11, 15, and 18. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Dose Expansion Colorectal Cancer (Arm B)
  In the dose expansion phase, Arm B will be open for 16 patients with colorectal adenocarcinoma. Patients must have histologic diagnosis and either locally advanced unresectable or metastatic disease and have previously received oxaliplatin, irinotecan, and a fluoropyrimidine. Eight patients will participate in the paired biopsy studies. Patient selected for biopsy must have a primary or metastatic non-bone site that is amenable to safe biopsy.

Primary Outcome Measure

Recommended Phase II Dose of the Combination of XL888 and Pembrolizumab as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Cycle length 21 days. Outcome determined on day 22 (after completion of cycle 1) ]

Locations (3)

Related coverage on Hipa.ai

• Pembrolizumab + XL888 Phase 1 Trial Assesses Doses in GI Cancers
  Pembrolizumab · May 22, 2026 · ClinicalTrials.gov

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