A Study of GQ1005 in Subjects With HER2-Expressing Advanced Solid Tumors

NCT06154343 | Unknown Phase 1

• 1 other identifier: GQ1005-102
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 20

Brief Summary

This is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of GQ1005 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

Conditions

HER2 Expressing or Mutated Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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).

  Up to 2 years

• 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.

  From first dose to the end of Cycle 1, 21 days

• Maximal Tolerance Dose (MTD) or recommended phase II dose (RP2D)

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

  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

Secondary Outcomes (10)

• Maximum concentration (Cmax) of GQ1005

  Up to2 years

• Time of peak plasma concentration (Tmax)

  Up to2 years

• Area under the plasma concentration time curve (AUC) of GQ1005

  Up to 2 years

• Overall response rate (ORR)

  Up to 2 years

• Duration of Response (DoR)

  Up to 2 years

Study Arms (2)

Dose Escalation

EXPERIMENTAL

GQ1005 will be administered intravenously every 21 days. Dose Escalation will be guided by Bayesian Optimal Interval (BOIN) Design. Multiple dose grouping

Drug: GQ1005

Dose Expansion

EXPERIMENTAL

GQ1005 at the recommended phase II dose (RP2D) will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or RP2D in different types of malignant solid tumor in four cohorts.

Drug: GQ1005

Interventions

GQ1005 DRUG

an antibody drug conjugate

Dose Escalation; Dose Expansion

Eligibility Criteria

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

You may qualify if:

• Voluntary agreement to provide written informed consent；
• Aged 18 years or older, both male and female.
• The expected survival time is more than 3 months.
• ECOG performance status Score 0 or 1.
• LVEF ≥ 50% by ECHO or MUGA scan within 28 days prior to the first dose of study drug.
• Histologically or cytologically confirmed malignancy with at least 1 measurable lesion as assessed by RECIST v1.1.
• Good organ function, confirmed by the following laboratory test results at Screening and within 7 days prior to the first dose of study drug:
• Platelet count ≥ 100,000/mm3; hemoglobin ≥ 9g/dL; ANC ≥ 1500/mm3; Serum CREA ≤ 1.5 × ULN, or estimated CREA clearance ≥ 60 mL/min (Cockcroft-Gault equation); ALT and AST ≤ 3 × ULN (≤ 5 x ULN if liver metastases are present); Total bilirubin ≤ 1.5 x ULN for subjects with Gilbert's syndrome or ≤ 2 x ULN for subjects with liver metastases at baseline; Prothrombin time and activated partial thromboplastin time ≤ 1.5 × ULN;
• Adequate washout period prior to the first treatment, defined as follows:
• Major surgery ≥ 4 weeks; radiotherapy ≥ 4 weeks (≥ 2 weeks if the radiotherapy is palliative stereotactic radiotherapy without abdominal involvement); seed-radioactive therapy ≥ 3 months; Nuclein therapy ≥ 3 months; autotransplantation ≥ 3 months; Hormone therapy ≥ 2 weeks or as per investigator's judgment (breast cancer subjects) Chemotherapy or targeted therapy (including antibody drug therapy) ≥ 2 weeks (5-FU-based drugs, folinic acid preparations and/or weekly paclitaxel therapy);
• weeks (or 5 half-lives, whichever is longer) (tyrosine kinase inhibitor);
• weeks (HER2-targeted biological therapy);
• weeks (nitrosourea or mitomycin C);
• weeks (any other chemotherapy/targeted therapy);
• weeks (Chinese patent medicine with clear antitumor indication) antitumor immunotherapy ≥ 4 weeks; Any investigational drug or treatment ≥ 4 weeks; Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4) ≥ 1 week; Organic Anion Transport Polypeptide (OATP) Inhibitors ≥ 1 week;

You may not qualify if:

• Clinically active brain metastases, defined as untreated and symptomatic, or requiring treatment with steroids or anticonvulsants to control associated symptoms. Subjects with treated asymptomatic brain metastases who do not require steroid therapy may be included in the study if they have recovered from the acute toxicity of radiation therapy.
• Cardiovascular dysfunction or clinically significant cardiac conditions, including but not limited to:
• Symptomatic CHF (New York Heart Association classes II to IV) or severe cardiac arrhythmia requiring treatment
• History of myocardial infarction or troponin levels consistent with myocardial infarction (defined by the American College of Cardiology guidelines) within 6 months prior to the first dose, and unstable angina pectoris within 6 months prior to the first dose of study drug;
• QTcF prolongation at Screening \>460 milliseconds (ms) (male) and \>470 ms (female) except for right bundle branch block.
• Clinically significant acute and chronic lung disease. (e.g., interstitial pneumonia, pulmonary infection, pulmonary fibrosis, and severe radiation pneumonitis), or subjects with suspected pulmonary disease based on imaging at screening, or subjects requiring oxygen.
• People with known hypersensitivity to recombinant humanized anti-HER2 monoclonal antibody-DXd conjugate drugs and their components or to humanized monoclonal antibody products.
• Poorly controlled pleural, ascites, or pericardial effusions.
• Toxicity that has not resolved from prior antineoplastic therapy, defined as toxicity (other than alopecia) that has not resolved to ≤ Grade 1 or baseline levels, is at the discretion of the investigator for the eligibility of subjects with chronic Grade 2 toxicities.
• The prior anthracycline exposure dose met the following criteria: adriamycin \> 500mg/m2; Epirubicin \>900mg/m2; Pirarubicin \> 950mg/m2; Mitoxanthraquinone \>120mg/m2; other (i.e. liposomal doxorubicin or other anthracycline \>equivalent to 500 mg/m2 of doxorubicin); If more than one anthracycline is used, the cumulative dose must not exceed the equivalent of 500 mg/m2 of doxorubicin.
• There is an active infection requiring treatment with intravenous antibiotics, antivirals, or antifungals.
• Known HIV infection.
• Active hepatitis C virus infection. (HCV antibody positive and HCV-RNA higher than the upper limit of reference value); Active hepatitis B virus infection. (HBsAg positive and/or HBcAb positive and HBV-DNA quantitation ≥2000 IU/ml);, to be eligible for enrollment, subjects with chronic hepatitis B will have to agree to monthly DNA testing and receive appropriate antiviral therapy as indicated.
• Live vaccine was administered within 30 days prior to the first dose of study drug.
• Previous or current evidence of any concomitant disease, treatment, or laboratory abnormality that the investigator believes may confound the results of the trial or interfere with subject participation and compliance.

Sponsors & Collaborators

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

Study Sites (20)

Chinese PLA general hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

The First Affiliated Hospital of Haerbin Medical University

Haerbin, Heilongjiang, 150007, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453199, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

Shengjing hospital of China medical universty

Shenyang, Liaoning, 110136, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, 276002, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, 264099, China

RECRUITING

Fudan university Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

The First Affiliated Hospital of Xi'an University

Xi'an, Shangxi, 710061, China

RECRUITING

Suining Central Hospital

Suining, Sichuan, 629099, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuang, 610042, China

RECRUITING

Tianjin medical university cancer institute & hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310020, China

RECRUITING

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: November 23, 2023
• First Posted: December 4, 2023
• Study Start: November 23, 2022
• Primary Completion: December 31, 2024
• Study Completion: July 30, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

CN (20)