CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05187182
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CA-4948 — DRUG
    Provided by Curis, Inc.
  • Nivolumab — BIOLOGICAL
    240 mg IV on Day 1 of each cycle
  • Pembrolizumab — BIOLOGICAL
    400 mg IV on Day 1 of every 3 cycles (C1D1, C4D1, C7D1,…) and dosing may continue for a max of 2 years
  • Trastuzumab — DRUG
    6 mg/kg IV loading dose on Cycle 1 Day 1 and 4 mg/kg IV on Day 1 of every subsequent cycle
  • mFOLFOX7 — DRUG
    Standard of care

Study Details

This is a phase I trial of CA-4948 in combination with FOLFOX/PD-1 inhibitor with or without trastuzumab for unresectable gastric, GEJ, and esophageal cancer. During the Dose Escalation portion of the study, different dose levels of CA-4948 in combination with FOLFOX/nivolumab will be evaluated by BOIN algorithm. Dose Expansion will include Cohorts A and B. Expansion Cohort A will enroll up to 12 patients with HER2 negative gastric, GEJ, and esophageal cancer at the expansion dose of CA-4948 determined during Dose Escalation and will use the same treatment regimen of FOLFOX/nivolumab. Expansion Cohort B will investigate CA-4948 at the dose determined during Dose Escalation in combination with FOLFOX/pembrolizumab and trastuzumab in up to 12 patients with HER2 positive disease; however, the initial 6 patients will be considered safety lead-in to confirm the safety and tolerability of this combination; if determined to be safe, an additional 6 patients will be enrolled for a total of 12 in Cohort B.

Key Dates

Start date
Jun 2, 2023
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation (CA4948 + FOLFOX + Nivolumab)
    * CA4948 (dose will depend on dose level assigned) twice daily by mouth. Standard of care mFOLFOX7 every 14 days. Nivolumab every 14 days. * Each cycle is 14 days.
  • Experimental: Dose Expansion Cohort A (CA4948 + FOLFOX + Nivolumab)
    * CA4948 (dose will be the recommended phase II dose found in the dose escalation portion of study) twice daily by mouth. Standard of care mFOLFOX7 every 14 days. Nivolumab every 14 days. * Each cycle is 14 days.
  • Experimental: Dose Expansion Cohort B (CA4948 + FOLFOX + Pembrolizumab + Trastuzumab)
    * CA4948 (dose will be the recommended dose found in the dose escalation portion of study) twice daily by mouth Standard of care mFOLFOX7 every 14 days. Pembrolizumab on day 1 of every 3 cycles. Trastuzumab every 14 days. * Each cycle is 14 days.

Primary Outcome Measure

Safety of regimen as measured by number of adverse events [ Time Frame: From start of treatment through 30 days after completion of treatment (estimated to be 15 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Patrick Grierson, M.D., Ph.D.
[email protected]
314-747-7689
Patrick Grierson, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Olivia Aranha, M.D., Ph.D. (SUB_INVESTIGATOR)
Matthew Ciorba, M.D. (SUB_INVESTIGATOR)
Kian-Huat Lim, M.D., Ph.D. (SUB_INVESTIGATOR)
Michael Iglesia, M.D., Ph.D. (SUB_INVESTIGATOR)
Katrina Pedersen, M.D. (SUB_INVESTIGATOR)
Rama Suresh, M.D. (SUB_INVESTIGATOR)
Benjamin Tan, M.D. (SUB_INVESTIGATOR)
Nikolaos Trikalinos, M.D. (SUB_INVESTIGATOR)
David DeNardo, Ph.D. (SUB_INVESTIGATOR)
Feng Gao, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
Washington University School of Medicine· St Louis, MO

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