Health TrialsbyHealthPanel

A Study of GQ1010 in Subjects With Advanced Solid Tumors

ConditionAdvanced Malignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneQuantum Healthcare (Suzhou) Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors with epithelial derived malignancy has relapsed or progressed following local standard treatments, or for which no standard treatment is available. Priority for inclusion but not limited to the following types of cancer: gastric adenocarcinoma/gastroesophageal junction cancer, breast cancer (triple negative and hormone receptor-positive, HER2 negative), colorectal cancer, cholangiocarcinoma, pancreatic cancer, endometrial cancer, ovarian cancer, cervical cancer, etc.

Disqualifiers

Is a lactating mother or pregnant as confirmed by pregnancy tests;

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Dose Escalation

    Drug

    Drug: GQ1010

  • Dose Expansion1

    Drug

    Drug: GQ1010 dose 1

  • Dose Expansion2

    Drug

    Drug: GQ1010 dose 2

  • Dose Expansion3

    Drug

    Drug: GQ1010 dose 3

  • phase II

    Drug

    Drug: GQ1010 RP2D

Treatment groups

260 Participants
are divided into 5 treatment groups
Group A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose Expansion1Experimental treatment 1 intervention
Group C: Dose Expansion2Experimental treatment 1 intervention
Group D: Dose Expansion3Experimental treatment 1 intervention
Group E: phase IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Screening up to study completion, an average of 1 year
2

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.

Time frame
21 days or 28 days
3

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.

Time frame
After each cohort completes the DLT observation period or has a DLT or becomes not DLT-evaluable
4

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.

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

Secondary outcomes

1

Maximum concentration (Cmax) of GQ1010

The pharmacokinetics(PK) profile of GQ1010

Time frame
Screening up to study completion, an average of 1 year
2

Time of peak plasma concentration (Tmax)

The pharmacokinetics(PK) profile of GQ1010

Time frame
Screening up to study completion, an average of 1 year
3

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

The pharmacokinetics(PK) profile of GQ1010

Time frame
Screening up to study completion, an average of 1 year
4

Terminal half-life (T1/2) of GQ1010

The pharmacokinetics(PK) profile of GQ1010

Time frame
creening up to study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GeneQuantum Healthcare (Suzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now