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Radiopharmaceutical

CAM-H2 for Breast or Gastric Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Precirix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Life expectancy > 6 months
HER2-positive locally advanced or metastatic breast cancer refractory to standard cancer treatment or HER2-positive locally advanced or metastatic gastric or GEJ cancer, refractory to standard cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it is safe and effective. The study will last up to 18 months and will test the treatment on patients with HER2-positive breast, gastric, or GEJ cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones from radionuclide therapies may include nausea, fatigue, radiation exposure-related risks like bone marrow suppression leading to low blood cell counts which increases infection risk; possible kidney damage; and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are expected to live for at least 6 more months.
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You have advanced breast cancer or stomach cancer that has not responded to standard treatments.
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If you have breast cancer, you should have tried at least two different treatments before. If you have gastric or GEJ cancer, you should have tried at least one treatment specifically targeting the HER2 protein.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical benefit rate (CBR) of CAM-H2 using the equation CBR = CR + PR + SD, as measured by the RECIST version 1.1 or as measured by RANO-BM
Proportion of patients achieving an objective response (CR or PR) with the use of CAM-H2 as measured by the RECIST version 1.1
Secondary outcome measures
Duration of response (DoR) in patients receiving CAM-H2
Overall survival (OS) for patients receiving CAM-H2
PFS in patients with brain metastases receiving CAM-H2
+2 more
Other outcome measures
Dose-limiting toxicity (DLT) rate of CAM-H2 assessed by toxicities occurring within the first cycle
Dosimetry - assessed by blood draws for blood and plasma gamma counts as well as by planar Whole body scans and SPECT/CT scans of the abdomen (kidney and liver) and of the target lesions
Maximum tolerated dose (MTD) of CAM-H2 assessed by the number and type of DLTs as defined in the protocol that occur during the first cycle
+2 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

PrecirixLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

CAM-H2 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04467515 — Phase 1 & 2
Breast Cancer, Gastric Cancer, Gastroesophageal Junction Cancer Research Study Groups: Dose Escalation and Expansion
Breast Cancer, Gastric Cancer, Gastroesophageal Junction Cancer Clinical Trial 2023: CAM-H2 Highlights & Side Effects. Trial Name: NCT04467515 — Phase 1 & 2
CAM-H2 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04467515 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are presently running this research trial?

"The current clinical trial has 13 operational sites, situated in cities such as Glen Burnie, Stanford and Maywood. In order to minimize travel costs associated with the study, it's best for participants to select a centre nearest them if they decide to enrol."

Answered by AI

What is the current sample size of this research project?

"This research requires 70 eligible individuals for participation. Subjects can join from two institutions, Advanced Molecular Imaging & Therapy in Glen Burnie and Stanford University Medical Center located in California."

Answered by AI

Has recruitment for this study commenced?

"According to clinicaltrials.gov, this research is actively enrolling participants and has been since September 14th 2021. The study was most recently updated on July 6th 2022."

Answered by AI
~4 spots leftby Mar 2025