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AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors

A Phase I/IIa Trial of AD1208, a Cell Cycle Inhibitor/MASTL Inhibitor, as a Single Agent or a Combination in Subjects With Any Progressive, Locally Advanced(Unresectable) or Metastatic Solid Tumors

NCT06911333•Avelos Therapeutics Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of AD1208 to determine the maximum tolerated dose(MTD) or maximumly administered dose(MAD) in any progressive, locally advanced (unresectable) or metastatic solid tumors. The main questions it aims to answer are: * Which dosage of AD1208 is safe and tolerable for participants? * What medical problems do participants have when taking AD1208? Participants will: * Take drug AD1208 every day up to 1 cycle at the least. * Visit the site once every 1 weeks for checkups and tests during cycle 1 and every 3 weeks from cycle 2 onwards. * Keep a diary of any adverse events and administrated drug

Detailed Description

\- Dose-escalation Part The treatment cycle is defined as 21 days and AD1208 will be administered orally once or twice a day from Day 1 to Day 21 in every 21-day cycle. The dose-escalation part is divided into phase 1a, which determines the Recommended dose of AD1208 in monotherapy, and phase 1b, which determines the RP2D of AD1208 in combination therapy.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects ≥19 years of age
•Willing to consent to participate in study and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
•Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, standard therapy does not exist or is not considered appropriate.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•Life expectancy of at least 12 weeks
•Subjects with adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory test within 2 weeks prior to the first administration of IP.
•Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months following the last dose of IP.
•Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time the partner is breastfeeding throughout the study period and for 6 months after the final administration of IP.

Exclusion Criteria

•Untreated active brain metastases.
•has leptomeningeal disease.
•unrecovered \> Grade 1 from the adverse event of prior therapy except for alopecia.
•has an active autoimmune disease requiring systemic treatment within the past 2 years.
•Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.
•Subject has received the following treatment;
•* prior anticancer monoclonal antibody treatment or investigational therapy
•* prior any chemotherapy
•* prior radiotherapy
•* Major surgery
+10 more criteria

Locations (3)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Key Dates

Start Date

March 11, 2025

Primary Completion Date

June 30, 2029

Completion Date

February 20, 2030

Last Updated

April 4, 2025

Enrollment

ESTIMATED participants

Conditions

Solid Tumor, AdultTumor, SolidSolid TumorSolid Tumor, Unspecified, AdultSolid Tumor CancerSolid Tumors Refractory to Standard TherapySolid Tumor in Advanced Stage

Interventions

AD1208

DRUG

Contacts

Soongyu Choi

CONTACT

82 2-6949-4355 cdm@avelostx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

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