Clinical trial NCT05483530: A Study to Investigate the Safety, Tolerability and Efficacy of HLX60 Combination With HLX10 in Subjects With Advanced or Metastatic Solid Tumors
Official title: A Phase 1 Clinical Study to Investigate the Safety, Tolerability and Efficacy of HLX60 (Anti-GARP Monoclonal Antibody) Combination With HLX10 (Anti-PD-1 Monoclonal Antibody) in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2022-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and tolerability of HLX60 combined with HLX10 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) and to evaluate the preliminary efficacy for each combination regimen.

Detailed description: Accelerated titration and "3 + 3" dose escalation were used in this trial . various doses of HLX60(anti-GARP) combined with HLX10(anti-PD-1) by intravenous infusion.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed advanced malignant solid tumor, who have failed or cannot receive the standard treatment;
* With at least one evaluable lesion according to RECIST v1.1 (for solid tumors);
* Patients must be able to supply adequate tumor tissue for biomarker (including the expression of PD-L1, GARP) analyses;
* Life expectancy longer than three months;
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria:

* Has a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participants with history of the second malignancy have been disease-free for \<3 years.
* Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening.
* Participant has unresolved AEs ≥ Grade 2 from prior anticancer therapy except for alopecia.
* Those who have received anti-GARP or anti-GARP/TGFβ complex antibody therapy.

Primary outcomes:
measure: Adverse event
timeFrame: Through study completion, assessed up to 2 years.
measure: Incidence of DLT
timeFrame: Up to 3 weeks.
measure: MTD
timeFrame: Up to 3 weeks.
measure: RP2D
timeFrame: Through study completion, assessed up to 2 years.
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Through study completion, assessed up to 2 years.
measure: Progression-free survival (PFS)
timeFrame: Through study completion, assessed up to 2 years.
measure: Overall survival(OS)
timeFrame: Through study completion, assessed up to 2 years.
measure: Cmax
timeFrame: 1 year
measure: Tmax
timeFrame: 1 year
measure: t1/2
timeFrame: 1 year
measure: AUC
timeFrame: 1 year
measure: PD
timeFrame: 1 year
measure: immunogenicity of HLX60
timeFrame: 1 year
measure: Potential prognostic and predictive biomarkers
timeFrame: 1 year
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Macquarie University Hospital & Nepean Hospital
Study officials:
References: