All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Monotherapy: Five dose levels of M108 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.

Combined with chemotherapy: Three dose levels of M108 will be tested by a conventional 3 + 3 study design.

The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (21 days).

Once the effective dose has been determined, 1\~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.

Monotherapy: Accelerated titration method, IV infusion Q3W; Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles)

M108

Zhaoyu Jin, Ph.D

Lin Shen, PhD

M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable Solid Tumors in China.

Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China

A Phase I, Multi-center, Open-label, Single-dose Escalation and Expansion, Dose Escalation and Expansion Combination With Chemotherapy Study Evaluating the Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China

defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)

Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA).

FutureGen Biopharmaceutical (Beijing) Co., Ltd

Part 1 is an open-label, dose-escalation study. Part 2 is an open-label, dose-expansion study.

Part 1: Andes-1537 subcutaneous injection, 100 to 1000 mg twice a week per 4-week cycle

Part 2: Andes-1537 subcutaneous injection, recommended phase 2 dose administered twice a week per 4-week cycle

Andes-1537 for Injection

Pamela Munster, MD

This is a first-in-human, open-label, dose escalation and expansion, 2-part study to determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available.

Part 1 is a dose-escalation study to establish the maximum tolerated dose based on dose-limiting toxicities and to evaluate the safety and tolerability of multiple doses of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available. Part 2 is an open-label, dose-expansion study to determine the safety, tolerability, and preliminary efficacy of Andes-1537 in patients with advanced solid tumors. In part 2, patients will be enrolled and receive the recommended phase 2 dose established in part 1 based on the safety, tolerability, pharmacokinetics, and preliminary efficacy data.

Phase 1 Safety and Tolerability Study of Andes-1537 for Injection in Patients With Advanced Unresectable Solid Tumors

A Phase 1 Open-label First-in-human Dose-escalating Safety and Tolerability Study Evaluating Subcutaneous Administration of Andes-1537 for Injection in Patients With Advanced Unresectable Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy is Available

Incidence of treatment-emergent adverse events

Changes in baseline safety laboratory tests

Measure maximum concentration, time to maximum concentration, area under the curve, clearance, volume of distribution, and half-life

Changes in tumor size from baseline measurements

Andes Biotechnologies

Group A: Phase 1-Dose Escalation: Adult patients.

Group B: Phase 1-Dose Escalation: Pediatric patients.

Phase 2a-Dose Extension: Adult patients with advanced unresectable solid tumors will be enrolled among two cohorts.

* Cohort 1: Activating BRAF V600 mutations (glioma patients only)
* Cohort 2: Activating BRAF non-V600 mutations

Phase 2a-RP2D Confirmation: Adult patients.

Phase 2a-RP2D Redefinition and Extension:

* Cohort 3: Activating BRAF V600 or activating non-V600 mutation
* Cohort 4: Activating BRAF non-V600 mutations

Phase 2a-RP2D Redefinition:

* Cohort 6A: Advanced activating BRAF-mutated solid tumors
* Cohort 7A: Advanced activating BRAF-mutated solid tumors
* Cohort 8A: Advanced activating BRAF-mutated solid tumors

FORE8394

Stacie Peacock Shepherd, MD, PhD

The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of FORE8394.

Dose Escalation (Part 1): To evaluate safety, pharmacokinetics, pharmacodynamics of FORE8394 in adult and pediatric patients with advanced BRAF- mutated tumors, and to identify the recommended Phase 2 Dose.

Dose Extension (Part 2): To access objective tumor response to FORE8394 treatment in adult and in adolescent patients with advanced BRAF- mutated tumors, to access RECIST, and to access pharmacokinetics, pharmacodynamics, and safety.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China	NCT04894825	Advanced Unrese...	M108 M108	18 Years - 75 Years	FutureGen Biopharmaceutical (Beijing) Co., Ltd
Phase 1 Safety and Tolerability Study of Andes-1537 for Injection in Patients With Advanced Unresectable Solid Tumors	NCT02508441	Advanced Unrese...	Andes-1537 for ...	18 Years -	Andes Biotechnologies
A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors	NCT02428712	Advanced Unrese... BRAF-mutated Tu...	FORE8394	10 Years -	Fore Biotherapeutics
Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China	NCT04894825	Advanced Unrese...	M108 M108	18 Years - 75 Years	FutureGen Biopharmaceutical (Beijing) Co., Ltd

Spots Global Cancer Trial Database for advanced unresectable solid tumors