Evaluating AD1208 for advanced 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

This study is testing a new drug called AD1208 to see if it is safe and tolerable for people with advanced solid tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Avelos Therapeutics Inc. (industry)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Seongnam-si, Gyeonggi-do and 2 other locations)
• Trial ID: NCT06911333 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and tolerability of the drug AD1208 in patients with progressive, locally advanced, or metastatic solid tumors. Participants will receive AD1208 daily for a minimum of one treatment cycle, with regular check-ups and monitoring for adverse effects. The study includes a dose-escalation approach to determine the maximum tolerated dose and the recommended phase 2 dose for both monotherapy and combination therapy. The trial will involve detailed tracking of participants' health and any side effects experienced during the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with confirmed progressive, locally advanced, or metastatic solid tumors that are refractory to previous treatments.

Not a fit: Patients with solid tumors that are amenable to standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have not responded to standard therapies.

How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced solid tumors, but the specific use of AD1208 is novel.

Eligibility criteria

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
* 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.

Where this trial is running

Seongnam-si, Gyeonggi-do and 2 other locations

• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)
• Severance Hospital — Seoul, South Korea (RECRUITING)
• Samsung Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Soongyu Choi

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