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

NCT06911333 | Recruiting Phase 1

• 1 other identifier: AVS1001-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Solid Tumor, Adult; Tumor, Solid; Solid Tumor; Solid Tumor, Unspecified, Adult; Solid Tumor Cancer; Solid Tumors Refractory to Standard Therapy; Solid Tumor in Advanced Stage

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  to determine maximum tolerated dose (MTD) or maximumly administered dose (MAD)

  At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes (11)

• Maximum Plasma Concentration [Cmax]

  At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

• A trough level or trough concentration [Ctrough]

  At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

• Time to peak drug concentration [Tmax]

  At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

• Half-life [T1/2]

  At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

• The area under the curve up to the last quantifiable time-point [AUC0-last]

  At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

Other Outcomes (7)

• metabolite 6 [M6]

  At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

• metabolite 8 [M8]

  At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

• metabolite 9 [M9]

  At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)

Study Arms (6)

Cohort 1

EXPERIMENTAL

AD1208 dose 1 (40mg bid) treatment arm

Drug: AD1208

Cohort 2

EXPERIMENTAL

AD1208 dose 2 (80mg QD) treatment arm

Drug: AD1208

Cohort 3

EXPERIMENTAL

AD1208 dose 3 (80mg bid) treatment arm

Drug: AD1208

Cohort 4

EXPERIMENTAL

AD1208 dose 4 (140mg bid) treatment arm

Drug: AD1208

Cohort 5

EXPERIMENTAL

AD1208 dose 5 (240mg bid) treatment arm

Drug: AD1208

Cohort 6

EXPERIMENTAL

AD1208 dose 6 (340mg bid) treatment arm

Drug: AD1208

Interventions

AD1208 DRUG

Up to 6 of cohorts will be applied sequentially in phase Ia part.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Clinically significant (i.e., active) cardiovascular disease
• known positive of human immunodeficiency virus (HIV) infection.
• Active hepatitis B or C subjects.
• known allergic reaction for active ingredients or inactive ingredients such as excipients of Investigational product.
• Live vaccine administered against infectious disease.

Sponsors & Collaborators

• Avelos Therapeutics Inc.: lead

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Soongyu Choi

CONTACT

82 2-6949-4355; cdm@avelostx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 4, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): February 20, 2030
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)