Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab (NCT04130516)

🧪 Interventions in This Study

• LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER (DRUG)
• Pembrolizumab - anti-PD-1 antibody (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. for treatment portion of study:
2. Has histopathologically confirmed locally advanced or metastatic solid tumor cancer (or lymphoma in Phase 1). The solid tumor cancer is further defined in some cohorts as:
3. Phase 1B monotherapy expansion cohort: Has melanoma, except uveal melanoma, and has previously received anti-PD-1/L1 therapy and is now not eligible for anti-PD-1 treatment in the judgement of the Investigator due to prior severe immune related adverse events, and has not received intervening cancer therapy since the anti-PD-1/L1 therapy.
4. Monotherapy Cohort M2: Has pancreatic, gastric, non small cell lung cancer (NSCLC), or colorectal cancer.
5. Monotherapy Cohort M3: Has cutaneous melanoma, and has previously received anti-PD-1/L1 therapy and is now not eligible for anti-PD-1 treatment in the judgement of the Investigator due to prior severe immune related adverse events, and has not received intervening cancer therapy since the anti-PD-1/L1 therapy.
6. Monotherapy Cohort M4: Has any solid tumor malignancy, except cutaneous melanoma, and has previously received anti-PD-1/L1 therapy and is now not eligible for anti-PD-1 treatment in the judgement of the Investigator due to prior severe immune related adverse events, and has not received intervening cancer therapy since the anti-PD-1/L1 therapy.
7. Monotherapy Cohort M5: Has metastatic uveal melanoma, and has received ≤ 2 prior lines of prior systemic therapy.
8. Phase 1B combination expansion cohort: Has any locally advanced or metastatic solid tumor cancer, and has first had a clinical benefit from, followed by documented disease progression on an anti-PD-1/L1 treatment administered either as monotherapy or in combination. Clinical benefit is defined as a complete or partial response of any duration or stable disease for at least 16 weeks with at least one scan showing stable disease. Patients should not have received intervening therapy that did not include anti-PD1/L1 between finishing anti-PD-1/L1 treatment and commencing study treatment. Disease progression on an anti-PD-1/L1 therapy is defined as both:
9. Having received anti-PD-1/L1 therapy at least twice if dosed every 4 weeks (q4w) or longer, at least 3 times if dosed every 3 weeks (q3w), or at least 4 times if dosed every 2 weeks (q2w) and,
10. Having documented clinical or radiographic progression of disease (PD) while on anti-PD-1/L1 therapy.
11. Combination Therapy Cohort C2: Has pancreatic, gastric, NSCLC, or colorectal cancer.
12. Combination Therapy Cohort C3: Has metastatic NSCLC expressing PD-L1 with a Tumor Proportion Score (TPS) ≥1% and ≤49% as determined by an FDA-approved test, and must not have EGFR or ALK genomic tumor aberrations or have demonstrated disease response on or following FDA-approved therapy for these aberrations, and is PD-1/L1 naïve, and is eligible for pembrolizumab as the standard of care or has no available standard of care.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (10 Sites)

• Cedars-Sinai Medical Center — Los Angeles, California
• Yale Cancer Center — New Haven, Connecticut
• Massachusetts General Hospital — Boston, Massachusetts
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico
• Columbia University Herbert Irving Comprehensive Cancer Center — New York, New York
• Memorial Sloan Kettering Cancer Center — New York, New York
• University of Pennsylvania — Philadelphia, Pennsylvania
• Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania
• MD Anderson Cancer Center — Houston, Texas
• The START Center for Cancer Care — San Antonio, Texas

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Solid Tumor, Adult clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.