A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors
This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.
• Age 18 years or older.
• Disease progression after standard of care (SOC) therapy or in the opinion of
• The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy.
• Phase 2a Part 1 i. Arm A - locally recurrent or metastatic melanoma. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
• ii. Arm B - locally recurrent or metastatic HNSCC. It must also meet the following criteria: 1) Disease progression to platinum-containing chemotherapy; 2) Failure to anti-PD-1/PDL1 blockade after receiving at least 2 doses alone or in combination.
• iii. Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies.
• iv. Arm D - locally recurrent or metastatic cSCC. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
• Phase 2a Part 2 i.v. Arm E - Histologically or pathologically confirmed NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement. Participants must have received at least one line but no more than three lines of prior anti-cancer therapies.
• Measurable disease per RECIST version 1.1.
• Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Life expectancy \> 12 weeks.
• Demonstrate adequate organ function as defined by acceptable laboratory testing results.
• Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011. WCBP must have a negative serum pregnancy test prior to W1D1.
⁃ Last dose of previous anticancer therapy ≥ 21 days, radiotherapy \> 21 days, or surgical intervention \> 21 days prior to the first dose of T3011.
⁃ Recovered from all prior anticancer therapy toxicities.
⁃ Willingness to provide fresh tumor biopsy specimens as specified in the Schedule of Assessments.
⁃ Capable of understanding and complying with protocol requirements.
⁃ Signed and dated institutional review board/independent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed.