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

Launched by AVELOS THERAPEUTICS INC. · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called AD1208 to see how safe it is for people with advanced solid tumors that are not responding to standard treatments. The main goal is to find out the highest dose of AD1208 that participants can take without serious side effects. If you join the trial, you will take AD1208 every day for at least one cycle, and you will have regular check-ups to monitor your health and any issues that may come up while taking the drug.

To be eligible for this trial, you need to be at least 19 years old and have a confirmed diagnosis of a solid tumor that has not responded to previous treatments. You should also be able to attend scheduled visits and follow the treatment plan. Participants will need to keep a diary of any side effects they experience. It’s important to know that certain health conditions may prevent you from joining, such as active brain metastases or serious heart disease. If you are considering participating, make sure to discuss it with your healthcare provider to see if it’s right for you.

Gender

ALL

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.