All Trials

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.

TrialFetch 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 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, or With the mTOR Inhibitor Everolimus in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative 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.

TrialFetch AI summary: This study enrolls adults with advanced or metastatic ER-positive, HER2-negative breast cancer (with limited prior systemic therapy) to receive OP-1250 (palazestrant), a complete estrogen receptor antagonist and degrader, in combination with either ribociclib (CDK4/6 inhibitor), alpelisib (PI3K inhibitor), or everolimus (mTOR inhibitor). Eligible patients must have measurable or evaluable disease and ECOG 0-1.

ClinicalTrials.gov ID: NCT05508906

A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast 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.

TrialFetch AI summary: This trial enrolls patients with advanced, locally unresectable or metastatic breast cancer of any HER2 status (including HER2-positive, HER2-low, HER2-ultralow, HER2-negative/triple-negative), investigating the combination of BNT323 (a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor) and BNT327 (a bispecific antibody targeting PD-L1 and VEGF-A), with some arms evaluating each agent as monotherapy. Eligible patients are generally pretreated with chemotherapy and must have measurable disease.

ClinicalTrials.gov ID: NCT06827236

Comparing Oral Drug Dosing Strategies in Older Patients With Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

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.

TrialFetch AI summary: This trial enrolls patients aged 65 or older with HR+/HER2- metastatic breast cancer who are eligible for combination endocrine therapy plus either palbociclib or ribociclib (CDK4/6 inhibitors), and randomizes them to receive either standard starting doses or lower, titratable doses of the selected CDK4/6 inhibitor. The goal is to determine which dosing approach better maximizes medication tolerance and reduces early discontinuation in this older population.

ClinicalTrials.gov ID: NCT06377852

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)

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: This trial enrolls adults with leptomeningeal disease from either triple-negative or HER2-positive breast cancer, using an intrathecal dendritic cell vaccine pulsed with HER2/HER3 peptides to stimulate an anti-tumor immune response in the CNS. Eligible patients must have an Ommaya reservoir or equivalent device for vaccine administration.

ClinicalTrials.gov ID: NCT05809752

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant 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: Eligible patients are adults with advanced, HER2-expressing solid tumors (including gynecologic, urothelial, biliary tract, breast, lung, and gastrointestinal cancers) who have progressed after at least two prior lines of standard therapy. All participants receive BL-M07D1, an investigational HER2-directed antibody-drug conjugate that delivers a topoisomerase I inhibitor (Ed-04) selectively to tumor cells via IV infusion every 21 days.

ClinicalTrials.gov ID: NCT06293898

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma

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: This trial enrolls adults with unresectable or metastatic, mismatch repair-proficient colorectal cancer or pancreatic ductal adenocarcinoma harboring vaccine-covered KRAS mutations who have progressed after first-line chemotherapy, and treats them with a mutant KRAS-targeted peptide vaccine plus balstilimab (anti-PD-1) and botensilimab (Fc-enhanced anti-CTLA-4). Immunotherapy-naive patients with measurable disease and good performance status are eligible.

ClinicalTrials.gov ID: NCT06411691

A Phase 1/2 Trial Evaluating the Combination of Temozolomide and the Ataxia Telangiectasia and Rad3-Related Inhibitor M1774

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: This trial enrolls adults with advanced metastatic solid tumors—particularly those with MGMT promoter hypermethylation or for whom temozolomide is standard therapy—and evaluates the combination of oral temozolomide with tuvusertib (M1774), a selective ATR kinase inhibitor that targets the DNA damage response pathway. The phase 2 focus is on patients with mismatch repair proficient/microsatellite stable colorectal cancer with MGMT promoter hypermethylation.

ClinicalTrials.gov ID: NCT05691491

A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal 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: This trial enrolls adults with metastatic or unresectable, RAS-mutant colorectal or pancreatic cancer (including KRAS G12D subsets), and tests oral RAS(ON) inhibitors—RMC-6236 (a multi-selective tri-complex RAS inhibitor) and RMC-9805 (a KRAS G12D-selective molecular glue)—either as monotherapy or combined with standard therapies such as mFOLFOX6, mFOLFIRINOX, gemcitabine/nab-paclitaxel, bevacizumab, or cetuximab. All patients must have ECOG 0-1 and adequate organ function.

ClinicalTrials.gov ID: NCT06445062

Phase I Trial of ZEN003694 (ZEN-3694) in Combination With Capecitabine in Patients With 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: This trial enrolls adults with metastatic or unresectable solid tumors—including those with prior exposure to fluorouracil or capecitabine—to receive the BET bromodomain inhibitor ZEN003694 (which disrupts BRD4-mediated oncogenic transcription) in combination with capecitabine. Expansion cohorts specifically include metastatic colorectal cancer.

ClinicalTrials.gov ID: NCT05803382