Clinical Trials for Small Cell Lung Cancer

A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase

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: Adults with newly diagnosed extensive-stage SCLC who are SSTR-positive on 68Ga-DOTA-TATE PET receive first-line carboplatin/etoposide/atezolizumab with or without [177Lu]Lu-DOTA-TATE, a somatostatin receptor–targeted radioligand delivering beta radiation. Maintenance is with atezolizumab ± [177Lu]Lu-DOTA-TATE; excludes prior ICI therapy and active autoimmune disease.

ClinicalTrials.gov ID: NCT05142696

Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma

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.

HealthScout AI summary: Enrolling adults (≥18; ≥16 for high-risk neuroblastoma or sarcoma) with measurable, GD2-positive recurrent/metastatic solid tumors (e.g., SCLC, high-risk neuroblastoma, sarcomas, melanoma) with ECOG 0–1 and adequate organ function. Two-step pretargeted radioimmunotherapy: IV GD2-SADA bispecific fusion protein (targets GD2; self-assembling/disassembling to enhance tumor avidity and renal clearance) followed after a set interval by 177Lu-DOTA to deliver beta radiation to tumor-retained antibody; dose-escalation with repeat cycles allowed.

ClinicalTrials.gov ID: NCT05130255

An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With 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.

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 safety and maximum tolerated dose of INBRX-106, a hexavalent OX40 agonist antibody, both alone and in combination with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors, including NSCLC, melanoma, and head and neck squamous cell carcinoma, who have progressed on standard therapies.

ClinicalTrials.gov ID: NCT04198766

A Phase 1-2 Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents in Subjects With 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.

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 targets adult patients with advanced solid tumors, including NSCLC, melanoma, liposarcoma, leiomyosarcoma, and SCCHN, who have exhausted standard treatments. It evaluates OR2805, a monoclonal antibody targeting CD163 to modulate tumor-associated macrophages, administered alone or with cemiplimab or docetaxel.

ClinicalTrials.gov ID: NCT05094804

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing 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.

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 assesses BT8009, a Bicycle Toxin Conjugate targeting Nectin-4, both as monotherapy and combined with pembrolizumab, in patients with advanced Nectin-4 expressing solid tumors such as urothelial carcinoma, breast, NSCLC, and ovarian cancers, who have progressed after prior treatment or lack standard therapy options. The study evaluates safety, pharmacokinetics, and preliminary efficacy, with previously reported promising response rates in treated urothelial cancer patients.

ClinicalTrials.gov ID: NCT04561362

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma

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.

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: The trial investigates the use of AG01, an anti-progranulin/GP88 monoclonal antibody, in patients with relapsed or refractory advanced solid tumors, including triple negative breast cancer, hormone-resistant breast cancer, non-small cell lung cancer, and mesothelioma, who have no remaining effective treatment options. AG01 is administered biweekly to evaluate its safety, tolerability, and preliminary anti-tumor activity.

ClinicalTrials.gov ID: NCT05627960

An Open-Label, Phase 1/2 Study to Evaluate Safety, Efficacy, and Pharmacokinetics of EU101, an Agonistic Anti-CD137 (4-1BB) Monoclonal Antibody in Patients With 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.

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 is focused on patients with metastatic or locally advanced solid tumors, specifically colorectal cancer and non-small cell lung cancer, investigating the safety and efficacy of EU101, an agonistic monoclonal antibody targeting the 4-1BB receptor to enhance immune response.

ClinicalTrials.gov ID: NCT04903873

First in Human Phase 1 Study of AOH1996 in Patients With Refractory 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.

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 refractory solid tumors unresponsive or declining standard treatments, evaluating the PCNA inhibitor AOH1996, which targets a cancer-specific variant to impair DNA replication and repair, dosed orally twice daily in a 28-day cycle.

ClinicalTrials.gov ID: NCT05227326

A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid 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.

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 such as melanoma and non-small cell lung cancer who have relapsed after standard treatments, testing the investigational agent ST-067 alone or with pembrolizumab and obinutuzumab to enhance immune response against tumor cells.

ClinicalTrials.gov ID: NCT04787042

Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

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.

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 with advanced solid tumors harboring RET gene abnormalities, including both NSCLC and other solid tumors, regardless of prior RET inhibitor exposure. Patients receive TAS0953/HM06 (vepafestinib), an oral selective RET tyrosine kinase inhibitor active against resistance mutations and designed for enhanced CNS penetration.

ClinicalTrials.gov ID: NCT04683250