Clinical Trials for Brain Tumor

Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT)

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 resectable brain tumors, including HER2-expressing or ERBB2-mutant brain metastases (HER2-high, HER2-low, or HER2-mutant) and HER2-expressing recurrent glioblastoma; includes patients with or without prior T-DXd. Patients receive perioperative trastuzumab deruxtecan (HER2-directed antibody-drug conjugate delivering a topoisomerase I inhibitor) to assess intratumoral penetration and preliminary efficacy.

ClinicalTrials.gov ID: NCT06058988

A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases

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: Adults with metastatic RCC and at least one measurable untreated or locally progressive brain metastasis (asymptomatic/mildly symptomatic, largely steroid-independent; ECOG 0–2) receive nivolumab (PD‑1 inhibitor) plus ipilimumab (CTLA‑4 inhibitor) with cabozantinib (MET/VEGFR/AXL TKI), with maintenance nivolumab/cabozantinib; prior systemic therapy allowed if no prior CTLA‑4, cabozantinib, or MET inhibitor. Primary aim is to improve intracranial PFS; a safety lead-in may omit ipilimumab if excess toxicity.

ClinicalTrials.gov ID: NCT05048212

Chronic Convection Enhanced Delivery of Topotecan for Recurrent Malignant Glioma

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 recurrent IDH1/2-mutant malignant glioma (WHO grade 3–4), KPS ≥70, with a stereotactically accessible enhancing lesion <32 cc after failing standard therapy receive intratumoral topotecan via chronic, pulsatile convection-enhanced delivery through an implanted pump and catheter. Topotecan is a topoisomerase I inhibitor; co-infused gadolinium enables imaging of distribution, with four 48-hour infusions over ~1 month and safety/response assessed by CTCAE and RANO.

ClinicalTrials.gov ID: NCT06666712

GPC-3 Chimeric Antigen Receptor T Cells FOR Recurrent GPC-3 Positive Glioblastoma

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 (≥18) with recurrent glioblastoma undergoing clinically indicated repeat resection whose tumor is GPC3-positive by IHC (≥25% with at least moderate intensity) and KPS ≥60. At surgery, patients receive a single intracavitary dose of autologous GPC3-targeted CAR T cells (GC33-derived) engineered to express IL-15 for enhanced expansion/persistence and incorporating an inducible caspase-9 (iCasp9) safety switch activatable with AP1903 if needed for toxicity control.

ClinicalTrials.gov ID: NCT06815432

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

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 evaluates IAM1363, an oral, irreversible tyrosine kinase inhibitor targeting HER2 mutations, in adult patients with advanced cancers harboring HER2 alterations who have relapsed or are intolerant to previous therapies, including a subgroup with brain metastases.

ClinicalTrials.gov ID: NCT06253871

A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

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 adults with advanced or metastatic solid tumors (including IDH-wildtype glioblastoma) harboring MTAP loss who have progressed on standard therapy, and tests TNG456, a selective, brain-penetrant PRMT5 inhibitor, as monotherapy or in combination with abemaciclib (CDK4/6 inhibitor). Eligible patients must have measurable disease, good performance status, and adequate organ function.

ClinicalTrials.gov ID: NCT06810544

A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants 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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors—including NSCLC, MSS colorectal cancer, pancreatic, gastric/GEJ adenocarcinoma, or head and neck squamous cell carcinoma—with good performance status, to receive BMS-986484 (an investigational anti-FAP biologic) as monotherapy or combined with nivolumab. Eligible patients must have measurable disease by RECIST v1.1 and ECOG 0-1.

ClinicalTrials.gov ID: NCT06544655

A Phase 1, Open-label Study of Oral BDTX-4933 in Patients With KRAS, BRAF and Other Select RAS/MAPK Mutation Positive Neoplasms

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 adults with advanced or metastatic solid tumors—such as NSCLC (KRAS non-G12C), melanoma (BRAF/NRAS), histiocytic neoplasms, thyroid carcinoma, colorectal carcinoma (BRAF Class II/III), or other BRAF-mutant tumors—who have exhausted standard therapies, to receive oral BDTX-4933, a brain-penetrant RAF/RAS clamp inhibitor targeting a range of RAS/MAPK pathway mutations. The study includes dose escalation and expansion phases to assess safety and preliminary efficacy.

ClinicalTrials.gov ID: NCT05786924

A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in 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: Eligible patients are adults with advanced or metastatic triple-negative breast cancer, high-grade serous ovarian, primary peritoneal, fallopian-tube, or serous endometrial cancer, all with TP53 mutation/loss and progression after at least one prior line of therapy. Participants receive AO-252, an investigational oral small-molecule inhibitor of TACC3 protein-protein interactions.

ClinicalTrials.gov ID: NCT06136884

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (OLAparib) Followed by Adjuvant Combination of DuRvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With BreAst Cancer Brain Metastases

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.

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 triple negative or BRCA-mutated, HER2-negative breast cancer with new brain metastases suitable for stereotactic radiosurgery, and tests the combination of SRS with olaparib (PARP inhibitor) followed by durvalumab (PD-L1 inhibitor) plus physician’s choice single-agent systemic therapy. Patients with prior whole brain radiotherapy, diffuse leptomeningeal disease, or previous combined PARP and immune checkpoint inhibitor therapy are excluded.

ClinicalTrials.gov ID: NCT04711824