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
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
Treatments tested in this trial
- Dose Escalation
- Dose Expansion1
- Dose Expansion2
- Dose Expansion3
- phase II
Treatment groups
260 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov