GQ1001 for Cancer

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen bySarina Piha-Paul

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?

Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors

Eligibility Criteria

Adults over 18 with advanced solid tumors that are HER2-positive, which means their cancer cells have more of a certain protein. They must have tried other treatments that didn't work or there's no standard treatment available. Their heart function should be good and they need to be relatively healthy overall (able to perform daily activities without much help).

Inclusion Criteria

I am 18 years old or older.

I have at least one tumor that can be measured.

My cancer is HER2-positive based on specific tests.

See 5 more

Exclusion Criteria

I have not had any cancer except skin cancer or in situ disease that was fully removed or treated in the last 2 years.

Cardiovascular dysfunction or clinically significant cardiac disease, including but not limited to: Medical history of symptomatic chronic heart failure (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment; Medical history of myocardial infarction or unstable angina within 6 months of the first treatment; Corrected QT interval by Fridericia (QTcF) prolongation of > 450 milliseconds (ms) in males and > 470 ms in females; Medical history of clinically significant lung disease (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), or patients who are suspected to have these diseases by imaging at screening or requirement for supplemental oxygen; Known hypersensitivity to either the drug substances or inactive ingredients in the drug product; Existing Grade ≥ 2 peripheral neuropathy; Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE version 5.0, Grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator; Cumulative anthracycline dose > 360 mg/m2 doxorubicin or equivalent; Uncontrolled infection requiring i.v. of antibiotics, antivirals or antifungals; Active infection with hepatitis C (e.g., detectable antibodies to hepatitis C virus [HCV]) or hepatitis B (e.g., hepatitis B surface antigen [HBsAg] positive) except subjects with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening, and these subjects must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated; Patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the Investigator, might confound the results of the trial, interfere with the patient's participation and compliance; Women who are lactating or pregnant, as confirmed by pregnancy test within 7 days before first treatment; Male and female subjects who are unwilling to use adequate contraceptive methods (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) during the study and for at least 7 months after the last dose of GQ1001.

I do not have active symptoms from brain metastases that need steroids or seizure medicines.

Treatment Details

Interventions

GQ1001 (Monoclonal Antibodies)

Trial OverviewThe trial is testing GQ1001, a new medication for people with specific types of advanced cancer where the tumor cells produce too much HER2 protein. It's in Phase I, meaning it's early in testing and the main goal is to find the right dose by starting low and gradually increasing.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

GQ1001 at the Dose Recommended for Dose Expansion will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or DRDE in different types of malignant solid tumor in four cohorts.

Group II: Dose EscalationExperimental Treatment1 Intervention

GQ1001 will be administered intravenously every 21 days. Dose Escalation will be guided by a modified 3+3 design.