Clinical trial · Interventional
A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors
A Phase 1a/1b Study of LY3321367, an Anti-TIM-3 Antibody, Administered Alone or in Combination With LY3300054, an Anti-PD-L1 Antibody, in Advanced Relapsed/Refractory Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY3300054 | Drug | — | UNRESOLVED |
| LY3321367 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- LY3321367 Dose Escalation
- description
- LY3321367 given intravenously (IV).
- interventionNames
- Drug: LY3321367
- type
- EXPERIMENTAL
- label
- LY3321367 + LY3300054 Dose Escalation
- description
- LY3321367 and LY3300054 given IV.
- interventionNames
- Drug: LY3321367
- Drug: LY3300054
- type
- EXPERIMENTAL
- label
- LY3321367 Dose Expansion
- description
- LY3321367 given IV.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * For Ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of advanced solid tumor. * For Phase 1a and 1b, prior PD-1 or PD-L1 therapy or other immunotherapy is allowed, if the following criteria are met: * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy. * Must have completely recovered or recovered to baseline prior to screening from any prior AEs occurring while receiving prior immunotherapy. * Must have provided tumor tissue sample, as follows: * For participants entering Ph1a: have submitted, if available, an archival tumor tissue sample. * For participants entering Ph1b: have submitted, a sample from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by 6 months of study enrollment (Ph1b). * Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Must have adequate organ function. * Have an estimated life expectancy of 12 weeks, in judgement of the investigator. Exclusion Criteria: * Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible). * Have received a live vaccine within 30 days before the first dose of study treatment. * If female, is pregnant, breastfeeding, or planning to become pregnant. * Have a history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's participation. * Have moderate or severe cardiovascular disease. * Have a serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including active or chronic infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment. * Use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, cyclosporine). \[Use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted\]. * Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection. * Evidence of interstitial lung disease or noninfectious pneumonitis.
References
Publications (1)
- DERIVEDHarding JJ, Moreno V, Bang YJ, Hong MH, Patnaik A, Trigo J, Szpurka AM, Yamamoto N, Doi T, Fu S, Calderon B, Velez de Mendizabal N, Calvo E, Yu D, Gandhi L, Liu ZT, Galvao VR, Leow CC, de Miguel MJ. Blocking TIM-3 in Treatment-refractory Advanced Solid Tumors: A Phase Ia/b Study of LY3321367 with or without an Anti-PD-L1 Antibody. Clin Cancer Res. 2021 Apr 15;27(8):2168-2178. doi: 10.1158/1078-0432.CCR-20-4405. Epub 2021 Jan 29. PMID 33514524