CAM-H2 for Breast or Gastric Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Precirix

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients with progressive, advanced/metastatic HER2-positive breast, gastric, and GEJ cancer with disease progression following anti-HER2 standard of care treatment. The study duration for each phase will be up to 18 months. The study is comprised of a Treatment Period, consisting of a maximum of 4 cycles (12 weeks per cycle) of study drug, and a 12-month Long-Term Follow-Up Period.

Research Team

Eligibility Criteria

This trial is for adults over 18 with advanced HER2-positive breast, gastric, or GEJ cancer that's gotten worse after standard treatments. They need to be relatively healthy (ECOG PS of 0-1), have good liver and kidney function, no severe illnesses or conditions that could interfere with the study, and a life expectancy over 6 months. Women who can have children must test negative for pregnancy and use two forms of birth control.

Inclusion Criteria

Adequate coagulation defined as an international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time <1.5 x the upper limit of the institutional normal range

Adequate hepatic function defined as an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x the upper limit of normal (ULN), or <5 x ULN in patients with liver metastases, and total bilirubin <2 x ULN

Neutrophil count >1500 cells/mm3 without growth factor support (14 days after last PEGylated granulocyte colony stimulating factor or 7 days after regular granulocyte colony stimulating factor)

See 14 more

Exclusion Criteria

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements

Uncontrolled diabetes defined as a fasting serum glucose > 2 x ULN or glycated hemoglobin levels > 8.5% at screening

Ongoing peripheral neuropathy of Grade > 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

See 26 more

Treatment Details

Interventions

CAM-H2 (Radiopharmaceutical)

Trial OverviewThe trial tests CAM-H2, a targeted radionuclide therapy in patients whose cancer has progressed despite treatment. It involves up to four cycles of treatment lasting 12 weeks each plus a follow-up period of one year to assess safety, dosage levels, how the body processes the drug (pharmacodynamics), and early signs of effectiveness.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention

The dose escalation phase of the study will be an open label 3 + 3 design, where at least 3 patients are treated at each dose level. Dose escalation will be done via increases of the nominal activity of CAM-H2 in cohorts of 3 to 6 patients. In the dose expansion phase of the study, the patients will be given the RDP2 determined in the dose escalation phase. Similar to the dose escalation phase, all patients will receive at least 1 cycle of CAM-H2.