Clinical Trials for Small Cell Lung Cancer

Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease (LMD)

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.

TrialFetch AI summary: This trial enrolls adults with leptomeningeal disease from melanoma (all subtypes, including primary CNS) or non-small cell lung cancer, allowing prior therapies, who receive escalating intrathecal nivolumab (anti-PD-1 immune checkpoint inhibitor) combined with standard intravenous nivolumab. The study tests concurrent intrathecal and intravenous administration to increase CNS drug levels for this population.

ClinicalTrials.gov ID: NCT03025256

Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: This trial enrolls anthracycline-naive adults with measurable, treatment-refractory soft-tissue sarcoma, triple-negative breast cancer, non-small cell lung cancer, cervical or ovarian cancer, or KRAS-mutant pancreatic cancer after at least two prior therapies. Patients receive escalating doses of SPEDOX-6, a doxorubicin formulation encapsulated in human serum albumin that may preferentially deliver drug to tumors with low FcRn expression; FcRn testing is not required.

ClinicalTrials.gov ID: NCT07064018

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 selected advanced solid tumors, measurable disease, and ECOG performance status 0–1 receive once-weekly intravenous MT-4561, an investigational drug designed to degrade BRD4. Dose escalation is followed by planned dose optimization and an assessment of MT-4561’s effect on oral midazolam pharmacokinetics.

ClinicalTrials.gov ID: NCT06943521

A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 advanced or metastatic HER3-positive solid tumors, including cutaneous melanoma, EGFR-mutated non–small cell lung cancer, and HR-positive/HER2-negative breast cancer, may be eligible if they are relapsed or refractory to standard therapy or have no suitable standard option. Treatment is intravenous ENV-501 every 3 weeks, an investigational HER3-targeted antibody–drug conjugate carrying the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT06956690

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 unresectable or metastatic KRAS G12D–mutated solid tumors are eligible for dose escalation; dose expansion is limited to pancreatic ductal adenocarcinoma after at least one prior systemic therapy. All receive IV ARV-806, an investigational PROTAC designed to degrade mutant KRAS G12D, weekly or every two weeks.

ClinicalTrials.gov ID: NCT07023731

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 measurable, unresectable locally advanced or metastatic epithelial carcinomas that have relapsed or are refractory after at least two prior treatment lines, have no standard options, and have ECOG performance status 0–1 receive DR-0202 every two weeks. DR-0202 is an investigational bispecific antibody designed to bring myeloid immune cells into contact with tumor cells; its tumor-cell target has not been disclosed.

ClinicalTrials.gov ID: NCT06999187

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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, progressing locally advanced or metastatic urothelial cancer enter dose escalation; expansion enrolls patients with Nectin-4–positive solid tumors identified by [64Cu]Cu-AKY-1189 imaging. All receive up to six cycles of [225Ac]Ac-AKY-1189, a Nectin-4–targeted radiopharmaceutical that delivers actinium-225 to tumor cells.

ClinicalTrials.gov ID: NCT07020117

A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV 324 in Adults With Hepatocellular Cancer or Squamous Cell Non-Small Cell Lung Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 advanced or unresectable hepatocellular carcinoma (Child-Pugh A) or advanced squamous non-small cell lung cancer (ECOG 0–1) receive intravenous ABBV-324, an investigational glypican-3–targeting antibody–drug conjugate. The hepatocellular carcinoma dose-optimization stage compares three ABBV-324 doses with lenvatinib; lung cancer enrollment is limited to dose escalation.

ClinicalTrials.gov ID: NCT06858813

An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 HR-positive, HER2-negative breast cancer that has progressed after endocrine therapy and a CDK4/6 inhibitor receive the investigational CDK2 inhibitor ECI830 alone or with ribociclib and fulvestrant; combination arms are also compared with ribociclib plus fulvestrant. Phase I additionally enrolls patients with other advanced CCNE1-amplified solid tumors.

ClinicalTrials.gov ID: NCT06726148

An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of WEF-001 in Participants With Advanced KRAS- Mutant Solid Tumours.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 measurable, progressive KRAS-mutant pancreatic, colorectal, lung, platinum-resistant serous ovarian, cholangiocarcinoma, or urothelial bladder cancer after at least one standard therapy receive intravenous WEF-001 monotherapy. WEF-001 is investigational and is proposed to exploit macropinocytosis in KRAS-mutant tumors; direct KRAS inhibition has not been established.

ClinicalTrials.gov ID: NCT07148128