CAM-H2 for Breast Cancer, Gastric Cancer, Gastroesophageal Junction Cancer

Stanford University Medical Center, Stanford, CA
Breast Cancer, Gastric Cancer, Gastroesophageal Junction CancerCAM-H2 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Similar Trials

1
ZW49
1
DAN-222
1
ORM-5029

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: 18 months

18 months
CBR in brain in patients receiving CAM-H2, using RANO-BM
Chromium
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
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
Duration of response (DoR) in patients receiving CAM-H2
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
Overall survival (OS) for patients receiving CAM-H2
PFS in patients with brain metastases receiving CAM-H2
Proportion of patients achieving an objective response (CR or PR) with the use of CAM-H2 as measured by the RECIST version 1.1
Proportion of patients on CAM-H2 who develop anti-drug antibodies (ADAs)
RDP2 for CAM-H2 assessed by the number and type of DLTs as defined in the protocol that occur during the first cycle
Safety and Tolerability - Incidence and severity of treatment-emergent adverse events (TEAEs)
Week 100
Progression Free Survival (PFS) for patients receiving CAM-H2

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
ZW49
1
DAN-222
1
ORM-5029

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Dose Escalation and Expansion
1 of 1

Experimental Treatment

70 Total Participants · 1 Treatment Group

Primary Treatment: CAM-H2 · No Placebo Group · Phase 1 & 2

Dose Escalation and Expansion
Drug
Experimental Group · 1 Intervention: CAM-H2 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Who is running the clinical trial?

PrecirixLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least six more months.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top