All Trials

A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

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: For adult men with metastatic castration-resistant prostate adenocarcinoma (including neuroendocrine differentiation but not pure small cell) progressing on ongoing androgen deprivation therapy and previously treated with at least one androgen receptor pathway inhibitor (ECOG 0–1, PSA ≥2). Patients receive oral valemetostat (investigational dual EZH1/EZH2/PRC2 inhibitor that reduces H3K27me3 to reverse transcriptional repression) in combination with oral darolutamide, with continued background ADT, in dose-escalation/expansion to assess safety and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT07244341

TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate 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: For men with de novo or recurrent metastatic hormone-sensitive prostate cancer on ongoing ADT (castrate testosterone; ECOG 0–2), including those with limited prior taxane and ≤6 months prior ARPI exposure (no ongoing darolutamide) and at least one metastatic lesion. Evaluates adding tulmimetostat (DZR123), an oral dual EZH1/EZH2 (PRC2) inhibitor, to darolutamide (and in dose-escalation also with abiraterone/prednisone) versus darolutamide alone while continuing ADT.

ClinicalTrials.gov ID: NCT07190300

Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, With Targeted Ablation of Resistant Lesions, in Patients With Non-Castrate Recurrent Oligometastatic Prostate 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: Adults with prostate adenocarcinoma post-prostatectomy (± prior adjuvant/salvage RT ≥3 months) who have biochemical recurrence with non-castrate testosterone and oligometastatic disease (<3 lesions on conventional imaging and PSMA PET/CT; ECOG 0–1) receive intradermal pTVG-HP/MVI-816, a plasmid DNA vaccine encoding prostatic acid phosphatase (PAP) to elicit PAP-specific T-cell responses, combined with nivolumab (PD-1 blockade). Lesions deemed treatment-resistant during therapy are ablated with targeted radiation.

ClinicalTrials.gov ID: NCT07090148

Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas

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: For children, adolescents, and young adults (≤21 years) with relapsed/refractory B7-H3 (CD276)–positive sarcomas (including osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, and other soft-tissue sarcomas) who have at least one lesion amenable to hypofractionated radiation. Treatment is hypofractionated radiation priming to ≥1 tumor site with fludarabine/cyclophosphamide lymphodepletion followed by IV infusion of autologous B7-H3–directed CAR T cells (genetically engineered T cells targeting the tumor antigen B7-H3).

ClinicalTrials.gov ID: NCT07222735

Phase I Study With Expansion Cohort of Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma

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: Adults (≥18) with metastatic or unresectable soft tissue sarcoma (RECIST-measurable, ECOG 0–1) who have progressed after 1–3 prior metastatic lines (ASPS allowed without prior refractoriness) and have had no prior PD-1/PD-L1/CTLA-4 therapy or zanzalintinib/cabozantinib. Treatment is oral zanzalintinib (XL092), a multikinase TKI targeting VEGFR2/MET/TAM (TYRO3/AXL/MER), combined with nivolumab (PD-1 inhibitor) plus ipilimumab (CTLA-4 inhibitor) induction, followed by maintenance nivolumab with ongoing daily zanzalintinib.

ClinicalTrials.gov ID: NCT06968988

A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).

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: Enrolling children and adolescents aged 2 to <18 years with relapsed/progressive/refractory somatostatin receptor–positive malignancies (e.g., neuroendocrine tumors, CNS tumors, lymphoma, other solid tumors) after ≥1 prior therapy, requiring SSTR expression by IHC and uptake on SSTR PET/SPECT greater than liver. Patients receive IV lutetium Lu 177 edotreotide (177Lu-DOTATOC) peptide receptor radionuclide therapy—a radiolabeled somatostatin analog targeting SSTR2 to deliver localized beta radiation—every 8 weeks for up to 6 doses (with amino acids for renal protection), either as monotherapy or after standard-of-care therapy.

ClinicalTrials.gov ID: NCT06441331

Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)

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: For adults with relapsed small cell lung cancer progressing after at least one prior platinum-based regimen (prior anti–PD-(L)1 allowed; ECOG 0–2; measurable disease; prior irinotecan allowed if not stopped for intolerance), this single-arm study evaluates irinotecan (days 1 and 8 every 21 days) combined with cirtuvivint (SM08502), an oral CDC2-like kinase (CLK) and DYRK inhibitor that modulates alternative pre-mRNA splicing (with downstream transcriptional effects including reduced Wnt-pathway gene expression). The trial dose-escalates to a recommended dose then expands to assess objective response rate, with PFS and OS as secondary outcomes.

ClinicalTrials.gov ID: NCT07155200

A Phase 1a/1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion

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: Enrolling adults with relapsed/refractory, incurable small cell lung cancer with ≥1 RECIST-measurable lesion and ECOG 0–1 (controlled, asymptomatic CNS metastases allowed if stable), excluding mixed SCLC/NSCLC histology and significant cardiac/QTc or retinal/ophthalmologic disease. Patients receive ST-001 (IV nanoparticle fenretinide, a synthetic retinoid that modulates sphingolipid metabolism via DES1/DEGS1 inhibition to increase dihydroceramides) as a 4-hour infusion daily for 5 consecutive days every 3 weeks in dose-escalation/expansion to define MTD and assess preliminary activity.

ClinicalTrials.gov ID: NCT06922539

Iadademstat and Radiation Therapy With Atezolizumab in Extensive Stage Small-cell Lung Cancer (ES-SCLC) Patients With Persistent, Recurrent or Progressive Disease After First Line Systemic Therapy

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: Adults with extensive-stage small-cell lung cancer with persistent/recurrent/progressive disease after first-line platinum-based therapy (including those initially treated as limited-stage who later recur with extensive disease), ECOG 0–2, RECIST-measurable disease, and at least one lesion suitable for SBRT plus a separate lesion amenable to mandatory pre- and post-SBRT biopsies; prior immune checkpoint inhibitor exposure is allowed and selected treated/asymptomatic brain metastases are permitted. Treatment is oral iadademstat (ORY-1001; covalent LSD1/KDM1A epigenetic inhibitor) combined with atezolizumab (PD-L1 antibody, 1680 mg IV q28d) and SBRT to a selected lesion, followed by maintenance iadademstat plus atezolizumab until toxicity or loss of benefit.

ClinicalTrials.gov ID: NCT07113691

Pragmatic Pilot Study of ctDNA Informed Immune Checkpoint Inhibitor De-escalation in Advanced/Recurrent Mismatch Repair Deficient (MMR-D)/Microsatellite Instability High (MSI-H) Endometrial Cancer Using Standard of Care Treatments

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: Adults with stage III (residual), stage IV, or recurrent MMR-D/MSI-H endometrial carcinoma eligible for standard first-line chemotherapy plus immune checkpoint inhibitor (no prior PD-1/PD-L1/CTLA-4 therapy; treated/stable brain metastases allowed). All receive usual chemo-immunotherapy and maintenance ICI, with a ctDNA blood test at ~1 year used to guide de-escalation: ctDNA-negative patients consider stopping maintenance ICI while ctDNA-positive patients continue maintenance ICI per standard care.

ClinicalTrials.gov ID: NCT07270666