All Trials

Ph 1/1b/2 Multicenter, Open-Label, FIH Dose Esc & Dose Exp Study to Assess Safety and Tolerability of Orally Administered PMD-026 as a Single Agent and in Combination in Patients With Metastatic or Locally Advanced (Inoperable) RSK2+ Breast Cancer

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.

TrialFetch AI summary: This trial enrolls adults with RSK2-positive, HR+/HER2- locally advanced or metastatic breast cancer who have progressed after CDK4/6 inhibitor plus endocrine therapy, testing the investigational oral RSK inhibitor PMD-026 (which targets all four RSK isoforms in the MAPK/PDK-1 pathway) as monotherapy and in combination with fulvestrant. Eligible patients must provide tumor tissue for RSK2 analysis and have measurable disease.

ClinicalTrials.gov ID: NCT04115306

A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing 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.

TrialFetch AI summary: This trial enrolls adults with recurrent or metastatic GRPR-expressing solid tumors (including mCRPC, HR+/HER2- breast, colorectal, cervical, melanoma, and NSCLC) who have progressed on at least two prior systemic therapies, and treats them with 212Pb-DOTAM-GRPR1, a radiolabeled peptide that targets the gastrin-releasing peptide receptor (GRPR) to deliver alpha particle radiation directly to tumor cells.

ClinicalTrials.gov ID: NCT05283330

A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients 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.

TrialFetch AI summary: Adults with advanced or metastatic solid tumors that are refractory to, have progressed after, or are intolerant to standard therapies may receive oral AMXI-5001, a novel dual PARP1/2 and microtubule polymerization inhibitor, as monotherapy in this open-label study. Participants must have ECOG 0-1 and measurable or evaluable disease; no concurrent cancer therapy or strong CYP3A4 modulators are allowed.

ClinicalTrials.gov ID: NCT04503265

A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia

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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors (including expansion cohorts for triple-negative breast cancer or gastric/gastroesophageal junction cancer) refractory to standard therapies, and patients with relapsed/refractory acute myeloid leukemia, to evaluate the safety and preliminary efficacy of BAL0891, a dual TTK/PLK1 mitotic checkpoint inhibitor, as monotherapy or in combination with carboplatin or paclitaxel.

ClinicalTrials.gov ID: NCT05768932

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally Advanced/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.

TrialFetch AI summary: This trial enrolls adults with unresectable locally advanced or metastatic solid tumors—including colorectal, triple-negative breast, melanoma, and ovarian cancer—who have progressed on or cannot receive standard therapies, to receive NM1F (a PVRIG/CD112R immune checkpoint inhibitor) alone or in combination with pembrolizumab. Key exclusions are active CNS involvement, prior PVRIG/CD226-axis therapy, and significant comorbidities.

ClinicalTrials.gov ID: NCT05746897

A Phase Ia/Ib, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of RSC-1255 in Patients With Advanced Solid Tumor 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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors who have exhausted standard therapies and provides investigational monotherapy with RSC-1255, an oral small-molecule inhibitor of V-ATPase targeting both mutant and wild-type RAS, with enhanced potency against KRAS-G13D and KRAS-G12V mutations. All participants receive RSC-1255, and no control arm is included.

ClinicalTrials.gov ID: NCT04678648

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.

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: 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

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients 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.

TrialFetch AI summary: Adults with incurable, locally advanced or metastatic solid tumors (e.g., NSCLC, HNSCC, melanoma, TNBC, GI, cervical, CRC, urothelial, clear cell RCC, HCC) receive RO7502175, an afucosylated anti-CCR8 IgG1 designed to deplete intratumoral Tregs via enhanced ADCC, as monotherapy or combined with PD-(L)1 inhibitors (atezolizumab or pembrolizumab). Eligible patients have ECOG 0–1, measurable disease, and no active infections, autoimmune disease, or untreated CNS metastases.

ClinicalTrials.gov ID: NCT05581004

A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System 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.

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 recurrent or rare primary CNS tumors (e.g., GBM, diffuse midline glioma, ependymoma, medulloblastoma, atypical/anaplastic meningioma) after standard therapy receive oral ONC206 monotherapy. ONC206 is an imipridone that non-competitively antagonizes DRD2/DRD3 and allosterically hyperactivates mitochondrial ClpP, aiming to trigger integrated stress response and apoptosis; dose-escalation with food-effect/PK assessment and potential expansion at RP2D.

ClinicalTrials.gov ID: NCT04541082

A Phase 1/2 Trial of CBL0137 (NSC# 825802) in Patients With Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma

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.

TrialFetch AI summary: Pediatric patients (12 months–21 years) with relapsed/refractory solid tumors or lymphoma, including CNS tumors; Phase 2 focuses on progressive/recurrent DIPG or other H3 K27–altered diffuse midline gliomas post-radiation. Single-arm IV CBL0137 (a FACT “chromatin-trapping” agent that activates p53, suppresses NF-κB, and induces interferon response) is given on Days 1 and 8 of 21-day cycles to define RP2D and assess antitumor activity.

ClinicalTrials.gov ID: NCT04870944