Clinical Trials for Other Solid Tumor

A Phase I Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab in Patients With Immune Checkpoint Inhibitor Refractory Non-Small Cell Lung Cancer

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: The trial investigates the safety and tolerability of TILT-123, an oncolytic adenovirus encoding TNF-alpha and IL-2, in combination with Pembrolizumab, for adult patients with non-small cell lung cancer refractory to immune checkpoint inhibitors, aiming to stimulate anti-tumor immune responses and establish the Maximum Tolerated Dose.

ClinicalTrials.gov ID: NCT06125197

Phase I/II Study Exploring the Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

Active drug

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

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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 evaluates the combination of the investigational drug APL-101, a selective c-MET inhibitor, with standard osimertinib therapy in adults with EGFR-mutated metastatic NSCLC, focusing on those who have been on osimertinib for 8 to 16 weeks without disease progression. The study aims to establish the maximum tolerated dose and assess progression-free survival and objective response rate.

ClinicalTrials.gov ID: NCT04743505

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

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 involves patients with advanced or metastatic solid tumors with SMARCA4 mutations, evaluating the investigational drug PRT3789, a novel SMARCA2 degrader, as monotherapy or combined with docetaxel. The study aims to determine the safety, tolerability, and optimal dosing, focusing on PRT3789's selective targeting mechanism to exploit synthetic lethality.

ClinicalTrials.gov ID: NCT05639751

A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies

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 involves adult patients with advanced solid tumors, including those with platinum-resistant ovarian cancer or cutaneous squamous cell carcinoma, assessing the safety and efficacy of OR502, a monoclonal antibody targeting LILRB2 on tumor-associated macrophages, alone and with cemiplimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT06090266

Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

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 involves patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations and evaluates the safety and efficacy of ORIC-114, a selective irreversible inhibitor targeting EGFR exon 20 mutations, in combination with amivantamab, a bispecific EGFR and MET receptor-directed antibody.

ClinicalTrials.gov ID: NCT06816992

First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer

Active drug

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

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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: Eligible patients are adults with estrogen receptor positive, HER2-negative, locally advanced or metastatic breast cancer who have progressed after prior CDK4/6 inhibitor and endocrine therapy, with limited prior lines of treatment in the metastatic setting. This study evaluates the investigational oral CDK4 inhibitor RGT-419B (selective for CDK4 with additional CDK2 activity and less CDK6 inhibition) given alone or with endocrine therapy.

ClinicalTrials.gov ID: NCT05304962

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC) and Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC)

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 HER2-positive metastatic breast, gastric, gastroesophageal junction, or esophageal adenocarcinoma who have progressed after standard therapy, testing the selective HER2 tyrosine kinase inhibitor zongertinib (BI 1810631) alone or in combination with HER2-targeted agents (T-DXd, T-DM1, trastuzumab, capecitabine). Eligible patients must have measurable disease and good performance status (ECOG 0-1).

ClinicalTrials.gov ID: NCT06324357

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

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

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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 enrolls adults (and selected adolescents) with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation, who have progressed after at least one prior therapy, to receive rezatapopt (PC14586)—a selective oral p53 reactivator targeting the Y220C mutant—as monotherapy. Patients must have ECOG 0-1 and measurable disease; cohorts include ovarian, lung, breast, endometrial, and other solid tumors, with KRAS wild-type status required for some.

ClinicalTrials.gov ID: NCT04585750

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

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 who have exhausted standard therapies, with an expansion cohort for untreated, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. Patients receive AB598, an anti-CD39 monoclonal antibody designed to amplify anti-tumor immune responses, as monotherapy or in combination with the PD-1 inhibitor zimberelimab and FOLFOX chemotherapy.

ClinicalTrials.gov ID: NCT05891171

Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: This trial enrolls adults with locally advanced or metastatic ROS1-positive NSCLC who are TKI-naïve, comparing the investigational selective ROS1/TRK/ALK inhibitor repotrectinib to crizotinib. Eligible patients may have had up to one prior systemic therapy and must not have co-occurring actionable mutations.

ClinicalTrials.gov ID: NCT06140836