A Study of GQ1010 in Subjects With Advanced Solid Tumors

NCT06464055 | Recruiting Phase 1

• 1 other identifier: GQ1010-101
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 5

Brief Summary

This is an open-label, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of GQ1010 and preliminary anti-tumor efficacy in advanced malignant solid tumor subjects

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Phase I/II: Incidence and Severity of Adverse Events (AEs)

  Incidence and severity of Treatment-emergent adverse events, treatment-related adverse events and serious adverse events, according to NCI-CTCAE Version 5.0 (The number of participants who had treatment-related side effects in population who had received one therapy at least). Incidence and severity of TEAEs, TRAE and SAE

  Screening up to study completion, an average of 1 year

• Phase Ia: Dose Limiting Toxicities (DLTs)

  Adverse events will be assessed using NCI CTCAE version 5.0 and will be evaluated by the investigator and the sponsor for the eligibility of DLT.

  21 days or 28 days

• Phase Ia: Maximal Tolerance Dose (MTD) or recommended doses for dose expansion (RDEs)

  The SRC will determine the MTD/RDEs based on the totality of data for all tested dose levels.

  After each cohort completes the DLT observation period or has a DLT or becomes not DLT-evaluable

• Phase Ib: Recommended phase II dose (RP2D)

  The SRC will also determine the RP2D based on the totality and efficacy of data for all tested dose levels.

  After each cohort completes the safety and efficacy evaluation, an average of 6 months

• Phase II: Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of CR and PR.

  Screening up to study completion, an average of 1 year

Secondary Outcomes (10)

• Maximum concentration (Cmax) of GQ1010

  Screening up to study completion, an average of 1 year

• Time of peak plasma concentration (Tmax)

  Screening up to study completion, an average of 1 year

• Area under the plasma concentration time curve (AUC) of GQ1010

  Screening up to study completion, an average of 1 year

• Terminal half-life (T1/2) of GQ1010

  creening up to study completion, an average of 1 year

• Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Screening up to study completion, an average of 1 year

Study Arms (5)

Dose Escalation

EXPERIMENTAL

GQ1010 will be administered intravenously every 21 days or every 14 days. Dose Escalation will be guided by Bayesian Optimal Interval (BOIN) Design. Multiple dose grouping

Drug: Dose Escalation

Dose Expansion1

EXPERIMENTAL

GQ1010 at the recommended doses for Expansion (RDEs) . Dose expansion will further evaluate the safety and tolerability in advanced malignant solid tumor subjects.

Drug: Dose Expansion1

Dose Expansion2

EXPERIMENTAL

GQ1010 at the recommended doses for Expansion (RDEs). Dose expansion will further evaluate the safety and tolerability in advanced malignant solid tumor subjects.

Drug: Dose Expansion2

Dose Expansion3

EXPERIMENTAL

GQ1010 at the recommended doses for Expansion (RDEs) . Dose expansion will further evaluate the safety and tolerability in advanced malignant solid tumor subjects.

Drug: Dose Expansion3

phase II

EXPERIMENTAL

GQ1010 at the recommended phase II dose (RP2D). Dose expansion will evaluate preliminary efficacy in different types of malignant solid tumor in five cohorts.

Drug: phase II

Interventions

Dose Escalation DRUG

Drug: GQ1010

Dose Escalation

Dose Expansion1 DRUG

Drug: GQ1010 dose 1

Dose Expansion1

Dose Expansion2 DRUG

Drug: GQ1010 dose 2

Dose Expansion2

Dose Expansion3 DRUG

Drug: GQ1010 dose 3

Dose Expansion3

phase II DRUG

Drug: GQ1010 RP2D

phase II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥18 years old.
• Is able to provide written informed consent and is willing and able to comply with the protocol prior to initiation of any study-related tests or procedures.
• Has a life expectancy of ≥ 3 months.
• Agreed to provide archived tumor tissue specimens (unstained 10 surgical specimens \[thickness 4-5μm\] was suggested or fresh tissue samples of primary or metastatic sites within 3 years.
• Note: Trop-2 expression was not used to confirm participant eligibility; Tissue samples will be used for subsequent analysis of Trop-2 expression levels and other biomarkers.
• Measurable tumor lesion based on Response Evaluation Criteria in Solids Tumors (RECIST) version 1.1.
• Subjects had confirmed disease progression during or after the most recent treatment for locally advanced or metastatic disease, or subjects would not benefit from the former treatment assessed by the investigator .
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• If of reproductive/child-bearing potential(male and female) must agree to use reliable contraceptive measures (include hormonal contraceptives, barrier contraception or abstinence) with their partners during and upon completion of the study and for at least 7 months after the last dose of study drug.
• Has adequate bone marrow reserve and organ function (no transfusion or hematopoietic-stimulating factor therapy within 14 days):
• Hemoglobin (HGB) ≥ 9 g/dl
• Absolute neutrophil count (ANC) ≥ 1,500/mm3,
• Platelet count (PLT) ≥ 100,000/mm3,.
• Serum creatinine ≤ 1.5 × ULN or creatinine clearance (Ccr) ≥ 50 ml/min (calculated according to the cockcroft-gault formula),
• Total bilirubin (TBIL) ≤ 1.5 × ULN (gilbert's syndrome, TBIL ≤ 3 × ULN),

You may not qualify if:

• Is a lactating mother or pregnant as confirmed by pregnancy tests;
• Clinically significant concurrent diseases, including but not limited to:
• Heart failure with New York Heart Association \[NYHA\] Grade II to IV
• Myocardial infarction, unstable angina pectoris, or stroke within 6 months prior to the first dose of study drug
• Newly diagnosed thromboembolic events requiring therapeutic intervention within 6 months prior to the first dose of study drug
• Severe aortic stenosis
• Uncontrolled arrhythmia
• Congenital long QT syndrome
• Prolonged QT interval (QTcF) as corrected by Fredericia \> 470 msec according to 12-lead ECG
• Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg) or diabetes (HbA1c ≥9.0%)
• Clinically significant active infection requiring systemic antibiotic, antiviral, or antifungal treatment
• Poorly controlled pleural effusion, pericardial effusion, or ascites with clinical symptoms requiring drainage (poorly controlled as carrying a drainage tube or drainage frequency ≥1 / week).;
• Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Has leptomeningeal carcinomatosis, has brain stem metastasis, spinal cord compression. A minimum of 4 weeks must have elapsed between the end of whole brain surgery and study enrollment. 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 have had other primary malignancies within the last 3 years (other than sufficiently resected non-melanoma skin cancer, cured in situ disease, cured other solid tumors, and/or contralateral breast cancer).
• Has a history of or currently have interstitial lung disease (including but not limited to pulmonary fibrosis, radiation pneumonia) that requires steroids, or cannot be ruled out by imaging; Patients who currently have active pneumonia or pulmonary function tests that confirm severe impairment of lung function, and patients who require oxygen inhalation.

Sponsors & Collaborators

• GeneQuantum Healthcare (Suzhou) Co., Ltd.: lead

Study Sites (5)

Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute

Beijing, China

RECRUITING

Department of Medical Oncology, Harbin Medical University Cancer Hospital

Harbin, China

RECRUITING

Tianjin medical university cancer institute & hospital

Tianjin, China

RECRUITING

Hubei Cancer Hospital

Wuhan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Interventions

Clinical Trials, Phase II as Topic

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Yan Shi

CONTACT

0512-66526166; shiy@genequantum.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 18, 2024
• Study Start: May 23, 2024
• Primary Completion (Estimated): May 23, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CN (5)