D3L-002 in Advanced Solid Tumors (Phase 1)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is the first-in-human, multicenter, open-label, single-arm Phase 1 study of D3L-002 given intravenously every 3 weeks in 21-day cycles. The trial uses a Bayesian Optimal Interval design to identify the maximum tolerated dose and the recommended Phase 2 dose, while collecting safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary tumor activity data. About 24 participants with metastatic or unresectable tumors that progressed after prior therapy or lack standard options will be enrolled. Key eligibility includes adequate organ function, ECOG 0-1, and consent to provide tissue and blood samples; major exclusions include prior TIGIT or PVRIG therapy and active autoimmune disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Ability to provide written informed consent and comply with study procedures
2. Age ≥18 years
3. Histologically confirmed metastatic or locally advanced incurable solid tumor that has progressed after ≥1 line of therapy or has no available standard treatment
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. Adequate organ function (hematologic, hepatic, renal)
6. Life expectancy ≥12 weeks
7. Willingness to provide tumor tissue (if available) and blood samples
8. Agreement to use effective contraception
9. Negative pregnancy test for participants of childbearing potential

Exclusion Criteria:

1. Prior anti-TIGIT or anti-PVRIG therapy
2. Recent anticancer therapy without adequate washout
3. Active or uncontrolled illness
4. Interstitial lung disease/pneumonitis
5. Active Central Nervous System (CNS) disease
6. Uncontrolled effusions
7. Unresolved ≥Grade 2 toxicities
8. Severe prior immunotherapy-related toxicity
9. Active autoimmune disease
10. Active infection
11. Active hepatitis B/C or HIV
12. Recent malignancy (exceptions apply)
13. Significant cardiovascular disease
14. Immunosuppressive therapy within 14 days
15. Live vaccine within 30 days
16. Pregnancy or breastfeeding
17. Hypersensitivity to study drug
18. Investigator-determined unsuitability

Where it's running

• D3 Bio Investigative Site 1101
  Macquarie Park, Australia Recruiting
• D3 Bio Investigative Site 1102
  Nedlands, Australia Recruiting
• D3 Bio Investigative Site 1204
  Cheongju-si, South Korea Recruiting
• D3 Bio Investigative Site 1202
  Seoul, South Korea Recruiting
• D3 Bio Investigative Site 1203
  Seoul, South Korea Recruiting
• D3 Bio Investigative Site 1201
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Medical Director
• Email: D3bio_CT@d3bio.com
• Phone: +86 21 61635900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.