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

NCT07168226 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-09-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • MetaFines

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-03-31
Completion
2027-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168226 on ClinicalTrials.gov