Solid Tumor, AdultPhase 1/2AD1208NCT06911333
AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing AD1208 in people with Solid Tumor, Adult and Tumor, Solid, run by Avelos Therapeutics Inc. at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor, Adult, Tumor, Solid, Solid Tumor
- What is being tested?
- AD1208
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 11 Mar 2025to 20 Feb 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 20Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Heeju Ahn, 82 31-787-8502, rp475@snubh.org
Keun-Wook Lee
- Recruiting
Severance Hospital
Seoul, 03722
Haeun Seong, 82 2-9008-7610, heseong712@yuhs.ac
Hyo Song Kim
- Recruiting
Samsung Medical Center
Seoul, 06351
Eunah Cho, 82 2-2148-7395, ea0416.jo@samsung.com
Jeeyun Lee
About this study
Official title: 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
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.
- Conditions
- Solid Tumor, Adult, Tumor, Solid, Solid Tumor, Solid Tumor, Unspecified, Adult, Solid Tumor Cancer, Solid Tumors Refractory to Standard Therapy
- Being tested
- AD1208
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD1208Drug
Up to 6 of cohorts will be applied sequentially in phase Ia part.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | AD1208 dose 1 (40mg bid) treatment arm Receives: Drug: AD1208 |
| Cohort 2 | Experimental | AD1208 dose 2 (80mg QD) treatment arm Receives: Drug: AD1208 |
| Cohort 3 | Experimental | AD1208 dose 3 (80mg bid) treatment arm Receives: Drug: AD1208 |
| Cohort 4 | Experimental | AD1208 dose 4 (140mg bid) treatment arm Receives: Drug: AD1208 |
| Cohort 5 | Experimental | AD1208 dose 5 (240mg bid) treatment arm Receives: Drug: AD1208 |
| Cohort 6 | Experimental | AD1208 dose 6 (340mg bid) treatment arm Receives: Drug: AD1208 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
to determine maximum tolerated dose (MTD) or maximumly administered dose (MAD)
Measured: At the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes (11)
Maximum Plasma Concentration [Cmax]
to characterize pharmacokinetic profile of AD1208
Measured: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
A trough level or trough concentration [Ctrough]
to characterize pharmacokinetic profile of AD1208
Measured: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Time to peak drug concentration [Tmax]
to characterize pharmacokinetic profile of AD1208
Measured: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Half-life [T1/2]
to characterize pharmacokinetic profile of AD1208
Measured: 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]
to characterize pharmacokinetic profile of AD1208
Measured: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Clearance [CL]
to characterize pharmacokinetic profile of AD1208
Measured: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Volume of distribution at steady state [Vss]
to characterize pharmacokinetic profile of AD1208
Measured: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
objective response rate [ORR]
to evaluate the preliminary antitumor activity
Measured: through study completion, an average of 1 year
disease control rate [DCR]
to evaluate the preliminary antitumor activity
Measured: through study completion, an average of 1 year
treatment duration
to evaluate the preliminary antitumor activity
Measured: through study completion, an average of 1 year
progression-free survival [PFS]
to evaluate the preliminary antitumor activity
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start11 Mar 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion20 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avelos Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911333
- Sponsor's protocol ID
- AVS1001-101
- Acronym
- AD1208
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06911333
- Acronym / sponsor ID
- AD1208 / AVS1001-101
- Conditions
- Solid Tumor, Adult, Tumor, Solid, Solid Tumor, Solid Tumor, Unspecified, Adult, Solid Tumor Cancer, Solid Tumors Refractory to Standard Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Avelos Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 20 Feb 2030 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AD1208AD1208 dose 1 (40mg bid) treatment arm |
| Cohort 2 | Experimental | Drug: AD1208AD1208 dose 2 (80mg QD) treatment arm |
| Cohort 3 | Experimental | Drug: AD1208AD1208 dose 3 (80mg bid) treatment arm |
| Cohort 4 | Experimental | Drug: AD1208AD1208 dose 4 (140mg bid) treatment arm |
| Cohort 5 | Experimental | Drug: AD1208AD1208 dose 5 (240mg bid) treatment arm |
| Cohort 6 | Experimental | Drug: AD1208AD1208 dose 6 (340mg bid) treatment arm |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD1208Up to 6 of cohorts will be applied sequentially in phase Ia part. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Safety and tolerability
Time frame: At the end of Cycle 1 (each cycle is 21 days)
to determine maximum tolerated dose (MTD) or maximumly administered dose (MAD)
11 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
A trough level or trough concentration [Ctrough]
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Time to peak drug concentration [Tmax]
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Half-life [T1/2]
Time frame: 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]
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Clearance [CL]
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Volume of distribution at steady state [Vss]
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
objective response rate [ORR]
Time frame: through study completion, an average of 1 year
disease control rate [DCR]
Time frame: through study completion, an average of 1 year
treatment duration
Time frame: through study completion, an average of 1 year
progression-free survival [PFS]
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor, Adult
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AD1208 in people with Solid Tumor, Adult and Tumor, Solid, run by Avelos Therapeutics Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soongyu Choi (82 2-6949-4355, cdm@avelostx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: At the end of Cycle 1 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.