All Trials

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

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.

TrialFetch AI summary: Adults with PIK3CA-mutated, ER-positive/HER2-negative locally advanced (recurrent/progressed) or metastatic breast cancer with measurable/evaluable disease who progressed on/after CDK4/6 inhibitor plus endocrine therapy and have had ≤1 prior systemic line in the advanced setting (no prior PI3K/AKT/mTOR inhibitors; diabetes requiring systemic therapy excluded). Participants are randomized to two oral dose levels of inavolisib (PI3Kα inhibitor targeting activating PIK3CA mutations) each combined with intramuscular fulvestrant, with efficacy and tolerability compared.

ClinicalTrials.gov ID: NCT07368998

Artificial Intelligence and Machine Learning-Enhanced Biomarker-dRiven CDK4/6 Inhibitor Rechallenge in HR+ HER2- Advanced Breast Tumors.

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.

TrialFetch AI summary: Adults with endocrine-sensitive unresectable/metastatic HR+/HER2− breast cancer and ECOG 0–2 who progressed after ≥6 months of prior metastatic CDK4/6 inhibitor therapy (or within 6 months of adjuvant CDK4/6i+endocrine therapy) undergo post-CDK4/6i tumor NGS and are eligible only if an AI/ML model (palbo-VNN) predicts CDK4/6 inhibitor sensitivity. AI-selected patients are randomized to rechallenge with a different CDK4/6 inhibitor (CDK4/6 blockade of G1–S transition) plus fulvestrant versus physician’s choice non-CDK4/6 standard systemic therapy.

ClinicalTrials.gov ID: NCT07227233

A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)

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.

TrialFetch AI summary: Adults (women or men) with ER-positive (≥10%), HER2-negative metastatic or unresectable locally recurrent breast cancer, ECOG 0–1, measurable/evaluable disease, known ESR1 mutation status, and progression after prior CDK4/6 inhibitor–based endocrine therapy (no prior chemotherapy for metastatic disease; prior fulvestrant allowed). Patients are randomized to capecitabine alone versus capecitabine plus elacestrant (an oral selective estrogen receptor degrader that binds and promotes degradation of ER to inhibit ER signaling), with an optional switch to elacestrant monotherapy at progression for ESR1-mutant patients initially assigned to capecitabine.

ClinicalTrials.gov ID: NCT07222215

A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART for Subjects With Relapsed or Refractory Metastatic Colorectal 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.

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: Adults with relapsed/refractory metastatic colorectal cancer that is GCC (GUCY2C)–positive by IHC, previously treated with fluoropyrimidine/oxaliplatin/irinotecan and appropriate biologics (anti-VEGF and anti-EGFR if RAS WT), with measurable extracranial disease and limited liver tumor burden (<7 lesions, largest <3 cm) and no curative surgical option. Patients undergo leukapheresis and receive a single infusion of autologous GCC19CART (LYL273), a GCC-targeted CAR T-cell therapy using a coupled GCC CAR plus CD19 CAR component intended to enhance activation/expansion in solid tumors.

ClinicalTrials.gov ID: NCT05319314

Evaluation of Circulating Immune Response After Histosonics in Colorectal Cancer (ECHO-CRC)

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.

TrialFetch AI summary: Enrolling adults with biopsy-confirmed metastatic microsatellite-stable colorectal cancer and at least one radiographically evident liver metastasis who are planned for standard-of-care histotripsy (ECOG 0–3, adequate organ function). Patients receive noninvasive focused ultrasound histotripsy (mechanical tumor disruption via acoustic cavitation) to one or more liver metastases with serial blood draws pre/post procedure to assess systemic immune modulation (T-cell clonal expansion and exhaustion markers).

ClinicalTrials.gov ID: NCT07361107

A Randomized Study of Nivolumab and Ipilimumab With and Without EXL01 in First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC)

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.

TrialFetch AI summary: Adults with treatment-naïve metastatic/advanced stage IV renal cell carcinoma with a clear-cell component (ECOG 0–2; measurable disease; select stable treated brain metastases allowed) receive standard nivolumab (PD-1 inhibitor) plus ipilimumab (CTLA-4 inhibitor) induction for 4 cycles followed by nivolumab maintenance, randomized to with or without oral EXL01. EXL01 is an investigational live biotherapeutic containing Faecalibacterium prausnitzii intended to modulate the gut microbiome and potentially enhance systemic immune tone/checkpoint inhibitor responsiveness.

ClinicalTrials.gov ID: NCT07128680

Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis

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.

TrialFetch AI summary: Adults with resectable, liver-confined colorectal cancer metastases (≥1 lesion ≥2 cm) scheduled for standard hepatectomy undergo percutaneous implantation of an intratumoral microdevice into a liver metastasis 3–5 days pre-op, with en bloc retrieval at surgery. The device locally releases microdoses of multiple anticancer agents (e.g., FOLFOX/FOLFIRI/FOLFIRINOX components, bevacizumab, doxorubicin, and immunotherapies including botensilimab [Fc-enhanced anti–CTLA-4], balstilimab [anti–PD-1], and AGEN2373) to assess tissue-level drug diffusion and pharmacodynamic response, focusing on procedural safety/feasibility rather than systemic treatment.

ClinicalTrials.gov ID: NCT07193862

Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)

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.

TrialFetch AI summary: Adults with hepatocellular carcinoma with radiographic macrovascular invasion (ECOG 0–2, Child-Pugh A or B7; extrahepatic metastases allowed; no prior systemic therapy) are randomized after physician selection of a first-line IO regimen to receive systemic therapy alone versus the same systemic therapy plus liver SBRT (5 fractions). Systemic options are atezolizumab (PD-L1) + bevacizumab (VEGF), single-dose tremelimumab (CTLA-4) + durvalumab (PD-L1), or nivolumab (PD-1) + ipilimumab (CTLA-4) induction followed by nivolumab maintenance, with SBRT as the investigational addition.

ClinicalTrials.gov ID: NCT07166406

Repurposing Celecoxib to Overcome Resistance to Immunotherapy in Advanced HCC (RECON Study)

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.

TrialFetch AI summary: Adults with advanced/metastatic, RECIST-measurable hepatocellular carcinoma (ECOG 0–2) and preserved hepatic function (excluding Child-Pugh ≥7B), without recent checkpoint inhibitor therapy (within 6 months) or significant cardiovascular/thromboembolic/GI bleeding risk, receive celecoxib (oral selective COX-2 inhibitor aimed at blocking COX-2/PGE2–mediated immunosuppression) continuously plus durvalumab (anti–PD-L1) every 28 days and a single priming dose of tremelimumab (anti–CTLA-4) on cycle 1 day 1. Treatment continues until progression or unacceptable toxicity with correlative biomarker sampling.

ClinicalTrials.gov ID: NCT07174570

A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer in Combination With Pembrolizumab as First-Line Treatment

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.

TrialFetch AI summary: Eligible patients are adults with previously untreated stage IV squamous or non-squamous NSCLC with PD-L1 TPS ≥50%, ECOG 0–1, measurable disease, and (for non-squamous) no actionable genomic alterations, excluding untreated CNS metastases and prior PD-(L)1 therapy. Treatment is petosemtamab (investigational EGFR×LGR5 bispecific antibody intended to inhibit tumor signaling and enhance immune-mediated activity) plus pembrolizumab (PD-1 inhibitor) as first-line therapy.

ClinicalTrials.gov ID: NCT07353957