UnknownPhase 1

Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors

United States, Australia, China96 participantsStarted 2020-07-07

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed informed consent form and able to comply with the protocol;
✓. Male and female subjects ≥18 years of age;
✓. ECOG PS of 0 or 1, the estimated life expectancy ≥ 3 months;
✓. LVEF ≥ 50% as determined by echocardiography (ECHO);
✓. Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2-positive (as defined below) that is relapsed or refractory to standard therapy or for which there is no standard therapy and progressed. Patients must have a least one measurable disease lesion. Tumor specimens to identify HER2 status should be obtained within the past 6 months.
✓. Adequate organ function confirmed at screening and within 7 days before the first treatment, as evidenced by:
✓. Adequate washout period before the first treatment as defined by:
✓. Patients without a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections or with a history of AIDS-defining opportunistic infections and have not had an opportunistic infection within the past 12 months may be enrolled per the discretion of the Investigator.

Exclusion criteria

✕. Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of chemotherapy or radiotherapy;
✕. Subjects with multiple primary malignancies within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral breast cancer);
✕. Cardiovascular dysfunction or clinically significant cardiac disease, including but not limited to:
✕. 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;

What they're measuring

Dose Limiting Toxicities (DLTs).

Timeframe: End of Cycle 1 (21-day cycle)

Maximum Tolerated Dose (MTD) or Dose Recommended for Dose Expansion (DRDE)

Timeframe: After each cohort completes the DLT observation period (Day 1 to Day 21 after the first dose of study treatment) or has a DLT or becomes not DLT-evaluable

Trial details

NCT IDNCT04450732

SponsorGeneQuantum Healthcare (Suzhou) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-01

Contact for this trial

Yan Shi

0512-66526166 shiy@genequantum.com

View on ClinicalTrials.gov More HER2-positive Breast Cancer trials