Home › Trials › NCT05277051

Testing GSK4381562 in patients with advanced solid tumors

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

Phase 1 Interventional GlaxoSmithKline · NCT05277051

This study is testing a new drug called GSK4381562 to see if it can safely help people with advanced solid tumors that haven't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment141 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Drugs / interventionsorlotamab, enoblituzumab, chemotherapy, immunotherapy, radiation
Locations24 sites (San Francisco, California and 23 other locations)
Trial IDNCT05277051 on ClinicalTrials.gov

What this trial studies

This study investigates the safety, tolerability, pharmacokinetics, and immunogenicity of GSK4381562 in patients with advanced solid tumors that have not responded to standard treatments. It is a first-time-in-human study focusing on participants with specific recurrent or metastatic solid tumors. The study will evaluate how the drug interacts with the body and its potential effectiveness in treating these challenging cancer cases.

Who should consider this trial

Good fit: Ideal candidates include individuals with loco-regionally recurrent or metastatic solid tumors, such as head and neck squamous cell carcinoma or non-small-cell lung cancer, who have no remaining curative treatment options.

Not a fit: Patients with early-stage tumors or those who have not yet exhausted 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 who have exhausted other therapies.

How similar studies have performed: Other studies involving similar investigational drugs for advanced solid tumors have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:

  * Is not a woman of childbearing potential (WOCBP) or
  * Is a WOCBP and using a contraceptive method that is highly effective with a failure rate of less than (\<)1 percent (\[%\] per year), during the intervention period and for specified time after end of study treatment.
  * A WOCBP must have a negative highly sensitive pregnancy test within 24-48 hours before the first dose of study intervention.
  * Requirement for Arm I only: Male participants agree to use contraception and for their female partner to use contraception, if applicable.
* Histological or cytological documentation of loco-regionally recurrent solid tumors where curative treatment options have been exhausted, or metastatic solid tumors; types as follows:

  * head and neck squamous cell carcinoma (HNSCC)
  * non-small-cell lung cancer (NSCLC)
  * breast cancer (BC)
  * clear cell renal cell cancer (ccRCC)
  * gastric cancer (GC)
  * colorectal cancer (CRC)
  * endometrial cancer (EC)
  * epithelial ovarian, fallopian tube, and primary peritoneal cancers- Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists.
  * Measurable disease per RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
* Life expectancy of at least 12 weeks.
* Adequate organ function, as defined in the protocol.
* For participants enrolled in a PK/PD cohort, participant agrees to a fresh tumor biopsy during Screening and at approximately 6-weeks after treatment initiation.

Exclusion Criteria:

* Prior treatment with the following therapies (specified time periods are from last dose of prior treatment to first dose of study intervention):

  * Any therapy directed against Polio virus receptor (PVR)-related immunoglobulin domain-containing (PVRIG) (COM701 or other anti-PVRIG monoclonal antibody \[mAb\]) or other cluster of differentiation (CD)226 axis receptor (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain \[TIGIT\] or CD96) at any time.
  * For Arm I only, prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
  * Other prior immunotherapy, chemotherapy, targeted therapy, biological therapy or radiation therapy within specified periods as defined in the protocol.
  * Investigational therapy: if the participant has participated in a clinical study and has received an investigational product within 4 weeks or 5 half-lives of the investigational product (whichever is shorter).
* Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
* Toxicity from previous anticancer treatment, including:

  * Greater than or equal to Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or
  * History of myocarditis of any grade during a previous treatment with immunotherapy
  * Toxicity related to prior treatment that has not resolved to less than or equal to (\<=) Grade 1. Non clinically relevant Grade 2 toxicities, not constituting a safety risk by investigator judgment are allowed.
* Participant has a known additional malignancy that progressed or required active treatment within the last 2 years.

Where this trial is running

San Francisco, California and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NeoplasmsAdvanced solid tumorsMetastatic solid tumorAnticancer agentsDostarlimabGSK4381562GSK4428859ABelrestotug
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.