NCT07168226

Phase 2 Cachexia Clinical Trial to Evaluate the Efficacy and Safety of ASCA101

A Multi-center, Randomized, Phase 2 Clinical Trial to Exploratively Evaluate the Efficacy and Safety of ASCA101 for the Treatment of Cachexia in Patients With Solid Tumor

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: MetaFines · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of ASCA101 for the treatment of Cachexia in solid tumor patients. The main questions it aims to answer are: Can the efficacy of ASCA101 in improving cachexia be evaluated based on changes in body weight measured by InBody after 12 weeks (3 cycles) of weekly administration, compared to baseline, for each dose group? Do participants experience adverse events during administration of ASCA101 and/or within 4 weeks after the end of administration? This clinical trial comprises two parts. \[Study 1. Active-Controlled, Open-Label Study\] Participants who provide written informed consent will undergo screening procedures. Those who meet all inclusion criteria and none of the exclusion criteria will be eligible for enrollment and will be randomized to receive either ASCA101 (at one of two dose levels: 24.32 or 32.43 mg/kg) or an active control. Participants will receive the investigational product over 3 cycles (12 weeks). Each cycle consists of 28 days. Subjects in the ASCA101 group will receive the investigational drug twice weekly for a total of 8 doses per cycle. Participants in the active control group (megace F suspension) will receive the drug orally once daily. \[Study 2. Placebo-Controlled, Double-Blind Study\] Participants who provide written informed consent will undergo screening procedures. Those who meet all inclusion criteria and none of the exclusion criteria will be eligible for enrollment and will be randomized to receive either ASCA101 (at one of two dose levels: 24.32 or 32.43 mg/kg) or placebo. Participants will receive the investigational product over 3 cycles (12 weeks). Each cycle consists of 28 days. Subjects in the ASCA101 group will receive the investigational drug twice weekly for a total of 8 doses per cycle. Participants in the placebo group will receive placebo in the same manner as the ASCA101 group.

Conditions

• Cachexia; Cancer

Interventions

Type	Name	Description
DRUG	Active Comparator	Megace F suspension 20mL, intake daily for 12weeks
DRUG	ASCA101 24.32mg/kg	ASCA101 Inj. 24.32mg/kg, twice a week for 12 weeks
DRUG	ASCA101 32.43mg/kg	ASCA101 Inj. 32.43mg/kg, twice a week for 12 weeks
DRUG	Placebo	0.9% normal saline injection

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-03-31
• Completion: 2027-07-31
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

6 sites across 1 country: South Korea