Clinical Trials for Small Cell Lung Cancer

A Phase 1/1b Study of IAM1363 in Patients with Advanced Cancers Harboring HER2 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.

TrialFetch AI summary: Adults with relapsed or refractory HER2-altered advanced cancers after progression on or intolerance of their last systemic therapy receive oral IAM1363, an investigational irreversible HER2 inhibitor designed to penetrate the brain. Patients with brain metastases may enroll unless they need immediate local therapy.

ClinicalTrials.gov ID: NCT06253871

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

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.

TrialFetch AI summary: Adults with previously treated, recurrent unresectable, locally advanced, or metastatic EGFR-expressing solid tumors are eligible if they are germline HLA-A*02 heterozygous and their tumors have lost HLA-A*02 expression. After lymphodepleting chemotherapy, patients receive a single infusion of A2B395, an allogeneic CAR T-cell therapy designed to target EGFR-positive cells while sparing healthy cells that retain HLA-A*02.

ClinicalTrials.gov ID: NCT06682793

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant 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.

TrialFetch AI summary: Patients with unresectable locally advanced or metastatic KRAS-mutant or KRAS-amplified solid tumors, including NSCLC, pancreatic ductal adenocarcinoma, and colorectal cancer, receive oral BBO-11818, a noncovalent pan-KRAS inhibitor, alone or with pembrolizumab, pembrolizumab plus platinum/pemetrexed chemotherapy, or cetuximab. Eligible patients must have measurable disease and ECOG performance status 0–1.

ClinicalTrials.gov ID: NCT06917079

A Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

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.

TrialFetch AI summary: Eligible patients have measurable, unresectable locally advanced or metastatic HER2-positive or HR-positive/HER2-negative breast cancer, KRAS-mutant colorectal cancer, or KRAS-mutant non-small cell lung cancer, with ECOG performance status 0–1. Treatment is oral BBO-10203, an investigational inhibitor of RAS-mediated PI3Kα activation, alone or with trastuzumab in the breast cancer cohorts.

ClinicalTrials.gov ID: NCT06625775

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.

TrialFetch AI summary: Patients with previously treated, locally advanced or metastatic TP53 Y220C–mutant solid tumors and ECOG performance status 0–1 may be eligible; the enrolling portion requires measurable disease and excludes tumors with a KRAS single-nucleotide variant. Participants receive oral rezatapopt, an investigational small molecule that stabilizes Y220C-mutant p53 to restore tumor-suppressor activity; earlier cohorts also evaluated rezatapopt with pembrolizumab.

ClinicalTrials.gov ID: NCT04585750

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study

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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic KRAS G12C–mutant NSCLC and ECOG performance status 0–1 receive oral BBO-8520 alone or with pembrolizumab. BBO-8520 is an investigational covalent inhibitor targeting both active and inactive KRAS G12C; pembrolizumab inhibits PD-1.

ClinicalTrials.gov ID: NCT06343402

Phase 1/2 Study of TSN1611 in Subjects with Advanced Solid Tumors Harboring KRAS G12D 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.

TrialFetch AI summary: Adults with locally advanced or metastatic KRAS G12D-mutant solid tumors who lack suitable standard treatment, or are refractory or intolerant to it, receive TSN1611 monotherapy. TSN1611 is an investigational oral inhibitor of both active and inactive KRAS G12D.

ClinicalTrials.gov ID: NCT06385925

First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

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.

TrialFetch AI summary: Adults with progressive, measurable stage IIIB/C or IV NSCLC and an EGFR or HER2 exon 20 insertion may enter dose escalation; later cohorts require an EGFR exon 20 insertion and 1–2 prior treatment lines, including platinum chemotherapy unless contraindicated. All participants receive oral STX-721, an investigational covalent inhibitor of exon 20–mutant EGFR and HER2 designed to largely spare wild-type EGFR.

ClinicalTrials.gov ID: NCT06043817

A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With 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.

TrialFetch AI summary: Adults with advanced solid tumors, measurable disease, and ECOG performance status 0–1 receive BMS-986507 (izalontamab brengitecan) plus either osimertinib or pembrolizumab. BMS-986507 is an EGFR/HER3-targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor; osimertinib inhibits EGFR, and pembrolizumab blocks PD-1.

ClinicalTrials.gov ID: NCT06618287

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With 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.

TrialFetch AI summary: Adults with advanced solid tumors that have progressed after standard therapy receive IV SMP-3124LP, a PEGylated liposomal CHK1 inhibitor targeting the DNA-damage response. Dose escalation includes several tumor types; expansion focuses on platinum-resistant ovarian cancer, triple-negative breast cancer, and anal squamous cell carcinoma.

ClinicalTrials.gov ID: NCT06526819