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RecruitingNCT06911333AD1208Updated Apr 4, 2025

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

A Phase 1/2 interventional study of AD1208 in Solid Tumor, Adult, Tumor, Solid and Solid Tumor, sponsored by Avelos Therapeutics Inc.. Recruiting at 3 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Avelos Therapeutics Inc. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study 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
Read the 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.
02

Conditions studied

  • 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

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 36 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

This is the only study on the registry with Avelos Therapeutics Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
  • 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.
  • Gastrointestinal (GI) track disease causing the inability to take oral medication, malabsorption syndrome or uncontrolled inflammatory GI disease.
  • having psychiatric illness/social situations that would limit compliance with study requirements.
  • women with a positive pregnancy test at screening test.
  • women who are breast feeding.
  • subject has any condition because of which, in the opinion of the investigator, the participation would not be in the best interest of the subject.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    AD1208 dose 1 (40mg bid) treatment arm

    Drug: AD1208

  • Experimental
    Cohort 2

    AD1208 dose 2 (80mg QD) treatment arm

    Drug: AD1208

  • Experimental
    Cohort 3

    AD1208 dose 3 (80mg bid) treatment arm

    Drug: AD1208

  • Experimental
    Cohort 4

    AD1208 dose 4 (140mg bid) treatment arm

    Drug: AD1208

  • Experimental
    Cohort 5

    AD1208 dose 5 (240mg bid) treatment arm

    Drug: AD1208

  • Experimental
    Cohort 6

    AD1208 dose 6 (340mg bid) treatment arm

    Drug: AD1208

Interventions

  • DrugAD1208

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

06

What researchers measure

Primary outcomes

  1. Safety and tolerability

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

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

Secondary outcomes

  1. Maximum Plasma Concentration [Cmax]

    to characterize pharmacokinetic profile of AD1208

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

  2. A trough level or trough concentration [Ctrough]

    to characterize pharmacokinetic profile of AD1208

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

  3. Time to peak drug concentration [Tmax]

    to characterize pharmacokinetic profile of AD1208

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

  4. Half-life [T1/2]

    to characterize pharmacokinetic profile of AD1208

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

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

    to characterize pharmacokinetic profile of AD1208

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

  6. Clearance [CL]

    to characterize pharmacokinetic profile of AD1208

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

  7. Volume of distribution at steady state [Vss]

    to characterize pharmacokinetic profile of AD1208

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

  8. objective response rate [ORR]

    to evaluate the preliminary antitumor activity

    Time frame: through study completion, an average of 1 year

  9. disease control rate [DCR]

    to evaluate the preliminary antitumor activity

    Time frame: through study completion, an average of 1 year

  10. treatment duration

    to evaluate the preliminary antitumor activity

    Time frame: through study completion, an average of 1 year

  11. progression-free survival [PFS]

    to evaluate the preliminary antitumor activity

    Time frame: through study completion, an average of 1 year

Other outcomes

  1. metabolite 6 [M6]

    to profile the metabolites of AD1208

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

  2. metabolite 8 [M8]

    to profile the metabolites of AD1208

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

  3. metabolite 9 [M9]

    to profile the metabolites of AD1208

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

  4. metabolite 10 [M10]

    to profile the metabolites of AD1208

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

  5. metabolite 11 [M11]

    to profile the metabolites of AD1208

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

  6. metabolite 12 [M12]

    to profile the metabolites of AD1208

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

  7. PPP2R2A

    to investigate Potential predictive biomarker related to AD1208

    Time frame: baseline, pre-intervention/procedure/surgery

07

Study locations

3 of 3 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 13620, Korea, Republic of
    • Heeju Ahn · Contact · rp475@snubh.org · 82 31-787-8502
    • Keun-Wook Lee · Principal investigator
    Recruiting
  • Severance Hospital
    Seoul, 03722, Korea, Republic of
    • Haeun Seong · Contact · heseong712@yuhs.ac · 82 2-9008-7610
    • Hyo Song Kim · Principal investigator
    Recruiting
  • Samsung Medical Center
    Seoul, 06351, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06911333
Lead sponsor
Avelos Therapeutics Inc.
Responsible party
Sponsor
First posted
Apr 4, 2025
Start date
Mar 11, 2025
Primary completion
Jun 30, 2029 (estimated)
Completion
Feb 20, 2030 (estimated)
Last update
Apr 4, 2025

Study contacts

Soongyu Choi
Contact
cdm@avelostx.com
82 2-6949-4355

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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