A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients

Kangabio

Status and phase: Enrolling; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: Envafolimab; Drug: KGX101 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07260305

KGX101ST102

Details and patient eligibility

About

This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards.

Enrollment: 57 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard of care, no further standard can be used, or standard of care is not fit;
2. Eastern cooperative oncology grous performance status of 0-1;
3. Has at least 1 measurable lesion per RECIST 1.1;
4. Has adequate organ and bone marrow function as per study which including hemoglobin > 90 g/L, platelet count >=100*10e9/L, absolute meutrophil count >=1.5*10e9/L;
5. Life expectancy of at least 3 months;
6. Provision of signed and dated written inform consent prior to any study-related procedures, sampling and analyses.

Exclusion criteria

1. Active known second malignancy except adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, breast cancer;
2. Patients with primary CNS malignancies;
3. Evidence of severe or uncontrolled systemic diseases, including: active infection, hypertension, chronically unhealed wound or ulcers;
4. Active autoimmnue disease requiring systemic treatment in the last 2 years, or immunodefiency which is on immunosuppressive therapy, chronic systemic or enteric steroid therapy;
5. History of pneumonitis, interstitial lung disease which require steroids or has current pneumonitis/ interstitial lung disease;
6. Any unresolved toxicities from prior therapy greater than CTCAE 5.0 grade 1.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 9 patient groups

KGX101 monotherapy-Dose level 1

Experimental group

Treatment:

Drug: KGX101 injection

KGX101 monotherapy-Dose level 2

Experimental group

Treatment:

Drug: KGX101 injection

KGX101 monotherapy-Dose level 3

Experimental group

Treatment:

Drug: KGX101 injection

KGX101 monotherapy-Dose level 4

Experimental group

Treatment:

Drug: KGX101 injection

KGX101 monotherapy dose expansion

Experimental group

Treatment:

Drug: KGX101 injection

KGX101 combo with Envafolimab-Dose level 1

Experimental group

Treatment:

Drug: KGX101 injection

Drug: Envafolimab

KGX101 combo with Envafolimab-Dose level 2

Experimental group

Treatment:

Drug: KGX101 injection

Drug: Envafolimab

KGX101 combo with Envafolimab-Dose level 3

Experimental group

Treatment:

Drug: KGX101 injection

Drug: Envafolimab

KGX101 combo with Envafolimab dose expansion

Experimental group

Treatment:

Drug: KGX101 injection

Drug: Envafolimab