Clinical Trials for Kidney Cancer

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors (ECOG 0-1, no active CNS metastases) to receive GI-102, a bispecific CD80–IL-2 variant fusion protein designed to selectively activate CD8+ T and NK cells, as monotherapy or combined with standard regimens, including pembrolizumab and trastuzumab deruxtecan (for HER2+ disease).

ClinicalTrials.gov ID: NCT05824975

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors that have progressed on at least three months of pembrolizumab, evaluating the investigational oral integrin αvβ8/αvβ1 inhibitor PLN-101095 as monotherapy or combined with pembrolizumab. Eligible patients must have no other effective treatment options and prior pembrolizumab resistance (primary or secondary).

ClinicalTrials.gov ID: NCT06270706

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043

Phase I Trial of [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with metastatic or inoperable somatostatin receptor–positive tumors (GI NETs, pheochromocytoma/paraganglioma, small cell lung, renal cell, and select head/neck cancers) confirmed by SSTR PET receive [212Pb]VMT-Alpha-NET, an SSTR2-targeted alpha-emitting radioligand (212Pb→212Bi) given IV every 8 weeks for up to 4 cycles, with an optional [203Pb] imaging/dosimetry lead-in. Excludes prior systemic radioligand therapy; allows treated/stable or asymptomatic CNS mets and requires adequate organ function.

ClinicalTrials.gov ID: NCT06479811

FORAGER-1: A Phase 1, Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer With FGFR3 Alterations

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with locally advanced/metastatic solid tumors—emphasizing urothelial carcinoma—harboring actionable FGFR3 alterations receive the selective FGFR3 inhibitor LOXO-435 (LY3866288) as monotherapy or combined with pembrolizumab ± enfortumab vedotin. Cohorts include FGFR inhibitor–naïve, post–FGFR inhibitor, and first-line mUC settings; key exclusions include uncontrolled CNS disease and significant ocular/cardiac risks.

ClinicalTrials.gov ID: NCT05614739

Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Treatment‑naïve adults with locally advanced or metastatic clear‑cell RCC (ECOG 0–1), including those with controlled, non–life‑threatening brain metastases, receive triplet therapy with 177Lu‑girentuximab (TLX250; CAIX‑targeted radiolabeled mAb delivering beta radiation), nivolumab (PD‑1 inhibitor), and cabozantinib (VEGFR/MET/AXL TKI). Key exclusions include prior systemic therapy for metastatic RCC, active autoimmune disease requiring therapy, recent major cardiovascular events, significant GI/fistula risk, uncontrolled hypertension, strong CYP3A4 modulators, and recent major surgery.

ClinicalTrials.gov ID: NCT05663710

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with unresectable or metastatic clear cell RCC (± sarcomatoid) that recurred during adjuvant anti–PD-(L)1 or within 24 months after completion, without prior VEGF/TKI or HIF-2α therapy, receive oral zanzalintinib (VEGFR2/MET/TAM multi-TKI) plus belzutifan (HIF‑2α inhibitor). Open-label, nonrandomized cohorts explore two zanzalintinib dose levels to assess safety and preliminary efficacy (ORR by BICR).

ClinicalTrials.gov ID: NCT07049926

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with ECOG 0–1: dose escalation enrolls any advanced solid tumor lacking standard options; expansion enrolls histologically confirmed ccRCC. Treatments include the oral HIF-2α inhibitor casdatifan (AB521) as monotherapy or combined with cabozantinib or the anti–PD-1 antibody zimberelimab.

ClinicalTrials.gov ID: NCT05536141

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial involves adult patients with advanced or metastatic solid tumors and evaluates the safety and therapeutic activity of GI-101, a bispecific fusion protein targeting CTLA-4 and the IL-2 pathway, as a single agent and in combination with pembrolizumab, lenvatinib, or radiotherapy.

ClinicalTrials.gov ID: NCT04977453

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

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial investigates GSK4381562, a monoclonal antibody targeting PVRIG to enhance NK and T cell activation, as monotherapy and in combination with anticancer agents such as dostarlimab, belrestotug, nelistotug, and GSK5764227 in patients with advanced solid tumors who lack standard treatment options. Eligible participants have locally recurrent or metastatic solid tumors, have progressed after standard therapies, and possess an ECOG performance status of 0-1 with adequate organ function.

ClinicalTrials.gov ID: NCT05277051