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Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

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Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Colorectal Carcinoma
Cholangiocarcinoma
Esophageal Adenocarcinoma
Gallbladder Carcinoma
Gastric Adenocarcinoma
GEJ Adenocarcinoma

Treatments

Drug: oxaliplatin
Drug: trastuzumab
Drug: leucovorin
Drug: fluorouracil
Drug: tucatinib
Drug: pembrolizumab
Drug: capecitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT04430738
SGNTUC-024

Details and patient eligibility

About

This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer.

The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below:

    • Cohorts 1A, 1B, 1C, and 1D

      • CRC
      • Gastric adenocarcinoma
      • GEJ adenocarcinoma
      • Esophageal adenocarcinoma
      • Cholangiocarcinoma
      • Gallbladder carcinoma
    • Cohorts 1E, 1F, 1G, and 2A

      • Gastric adenocarcinoma
      • GEJ adenocarcinoma
      • Esophageal adenocarcinoma
    • Cohort 2B

      • CRC
  • Participants must be candidates to receive an oxaliplatin-based regimen as part of their standard-of-care treatment for all cohorts, except Cohort 1G.

  • HER2+ disease, as determined by historic or local laboratory testing

  • Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as determined by the investigator

  • Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the investigator

  • Eastern Cooperative Oncology Group Performance Status score of 0 or 1.

Exclusion criteria

  • History of known hypersensitivity to planned study treatment
  • Known to be positive for Hepatitis B or C
  • For Cohorts 2A and 2B: prior anti-HER2 therapies
  • For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

40 participants in 9 patient groups

Cohort 1A
Experimental group
Description:
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Treatment:
Drug: fluorouracil
Drug: tucatinib
Drug: leucovorin
Drug: trastuzumab
Drug: oxaliplatin
Cohort 1B
Experimental group
Description:
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Treatment:
Drug: fluorouracil
Drug: tucatinib
Drug: leucovorin
Drug: trastuzumab
Drug: oxaliplatin
Cohort 1C
Experimental group
Description:
Tucatinib + trastuzumab + CAPOX given in 21-day cycles
Treatment:
Drug: capecitabine
Drug: tucatinib
Drug: trastuzumab
Drug: oxaliplatin
Cohort 1D
Experimental group
Description:
Tucatinib + trastuzumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles and trastuzumab given every 21 days
Treatment:
Drug: fluorouracil
Drug: tucatinib
Drug: leucovorin
Drug: trastuzumab
Drug: oxaliplatin
Cohort 1E
Experimental group
Description:
Tucatinib + trastuzumab + pembrolizumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles, trastuzumab given in 21-day cycles, and pembrolizumab given in 42-day cycles
Treatment:
Drug: pembrolizumab
Drug: fluorouracil
Drug: tucatinib
Drug: leucovorin
Drug: trastuzumab
Drug: oxaliplatin
Cohort 1F
Experimental group
Description:
Tucatinib + trastuzumab + pembrolizumab + CAPOX. Tucatinib, trastuzumab, and CAPOX given in 21-day cycles and pembrolizumab given in 42-day cycles.
Treatment:
Drug: capecitabine
Drug: pembrolizumab
Drug: tucatinib
Drug: trastuzumab
Drug: oxaliplatin
Cohort 1G
Experimental group
Description:
Tucatinib + trastuzumab + pembrolizumab. Tucatinib and trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Treatment:
Drug: pembrolizumab
Drug: tucatinib
Drug: trastuzumab
Cohort 2A
Experimental group
Description:
Tucatinib + trastuzumab + pembrolizumab + (FOLFOX or CAPOX). Either (1) tucatinib and FOLFOX given in 14-day cycles or (2) tucatinib and CAPOX given in 21-day cycles. Trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Treatment:
Drug: capecitabine
Drug: pembrolizumab
Drug: fluorouracil
Drug: tucatinib
Drug: leucovorin
Drug: trastuzumab
Drug: oxaliplatin
Cohort 2B
Experimental group
Description:
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles.
Treatment:
Drug: fluorouracil
Drug: tucatinib
Drug: leucovorin
Drug: trastuzumab
Drug: oxaliplatin

Trial contacts and locations

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Central trial contact

Seagen Trial Information Support

Data sourced from clinicaltrials.gov

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