Study of ZGGS18 in Patients With Advanced Solid Tumors

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Biological: ZGGS18 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05584800

ZGGS18-001

Details and patient eligibility

About

A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors

Enrollment: 222 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Life expectancy ≥ 3 months;
• Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.

Exclusion criteria

• The investigator considers that any subjects are not suitable to participate in the trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

222 participants in 2 patient groups

Dose Escalation

Experimental group

Treatment:

Biological: ZGGS18 for Injection

Biological: ZGGS18 for Injection

Dose Expansion

Experimental group

Description:

Tumor type: colorectal cancer，pancreatic cancer

Treatment:

Biological: ZGGS18 for Injection

Biological: ZGGS18 for Injection