Clinical Trials for Rectal Cancer

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients

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.

HealthScout AI summary: This trial enrolls adults with HLA-A*11:01-positive, metastatic or unresectable solid tumors harboring a G12D mutation in KRAS, NRAS, or HRAS who have progressed on standard therapy, and treats them with lymphodepleting chemotherapy followed by autologous T-cells engineered with a murine T-cell receptor targeting the G12D RAS mutation, plus high-dose IL-2. The investigational therapy specifically redirects T-cells to recognize and kill G12D-mutant RAS cancer cells presented by HLA-A*11:01.

ClinicalTrials.gov ID: NCT03745326

A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With 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.

HealthScout AI summary: This trial enrolls adults with advanced, relapsed or refractory solid tumors known to express ADAM9—including NSCLC adenocarcinoma, cholangiocarcinoma, colorectal, and pancreatic cancers—to receive MGC028, an investigational antibody-drug conjugate targeting ADAM9 with a topoisomerase I inhibitor payload. Patients must have measurable disease and accessible tissue for testing; prior treatment limits apply in expansion cohorts.

ClinicalTrials.gov ID: NCT06723236

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1

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.

HealthScout AI summary: This trial enrolls adults with unresectable or metastatic solid tumors harboring a KRAS G12C mutation, including those with NSCLC and other tumor types who have exhausted standard options. Patients receive the investigational KRAS G12C inhibitor adagrasib (MRTX849) as monotherapy or in combination with pembrolizumab, cetuximab, or afatinib.

ClinicalTrials.gov ID: NCT03785249

A Phase I/IIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients With Solid Tumors That Are Known to be Fibroblast Activation Protein (FAP)-Positive

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.

HealthScout AI summary: This trial enrolls adults with advanced, FAP-positive solid tumors who have progressed on or lack standard therapy, using [203Pb]Pb-PSV359 SPECT imaging to confirm FAP expression and [212Pb]Pb-PSV359, a FAP-targeted alpha-emitting peptide-radiopharmaceutical, for systemic therapy.

ClinicalTrials.gov ID: NCT06710756

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors (SYLVER)

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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors that are mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H), including those with previously treated colorectal or endometrial cancer, to receive the investigational oral Werner DNA helicase (WRN) inhibitor GSK4418959—alone or combined with a PD-1 inhibitor—to target DNA repair vulnerabilities in these tumors. Patients must have exhausted standard treatment options and have good performance status.

ClinicalTrials.gov ID: NCT06710847

An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of WEF-001 in Participants With Advanced KRAS- Mutant Solid Tumours.

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.

HealthScout AI summary: Adults with advanced/metastatic KRAS‑mutant solid tumors (e.g., PDAC, CRC, NSCLC, platinum‑resistant serous ovarian, cholangiocarcinoma, urothelial) after at least one prior therapy, ECOG 0–1, receive WEF‑001 monotherapy. WEF‑001 is a first‑in‑class macropinocytosis‑exploiting conjugate designed to selectively deliver a cytotoxic payload to KRAS‑mutant tumors; dose‑finding followed by expansion cohorts.

ClinicalTrials.gov ID: NCT07148128

A Phase 1 Study of ASP5834 in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies With KRAS Mutations or KRAS Amplifications

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.

HealthScout AI summary: Adults with unresectable/metastatic solid tumors harboring KRAS G12V/D/C/R/A or G13D mutations or KRAS amplification (ECOG 0–1, measurable disease) receive IV ASP5834, a first‑in‑human pan‑KRAS targeted protein degrader designed to eliminate multiple KRAS variants; dose-expansion includes PDAC, NSCLC, and other non-CRC tumors. Separate colorectal cancer cohorts test ASP5834 combined with panitumumab in KRAS‑mutant mCRC after standard therapies.

ClinicalTrials.gov ID: NCT07094204

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic Select 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.

HealthScout AI summary: Adults with previously treated, unresectable advanced/metastatic solid tumors (NSCLC, HNSCC, ESCC, left‑sided CRC) receive ALX2004 monotherapy, an investigational EGFR‑targeted antibody–drug conjugate carrying a topoisomerase I inhibitor payload designed for bystander effect. Excludes candidates for curative local therapy, rapidly progressive disease, short life expectancy, and prior exposure to topoisomerase I inhibitor ADCs.

ClinicalTrials.gov ID: NCT07085091

A Phase 1/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered 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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors harboring KRAS alterations (any missense mutation or amplification) and no standard options receive the investigational oral pan‑KRAS inhibitor AMG 410 (dual-state, noncovalent inhibitor selective over HRAS/NRAS) as monotherapy or combined with pembrolizumab (solid tumors) or panitumumab (CRC/PDAC). Includes multiple tumor types (e.g., NSCLC, CRC, PDAC) with measurable disease and ECOG 0–1; treatment continues until progression or intolerance.

ClinicalTrials.gov ID: NCT07094113

An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours

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.

HealthScout AI summary: Adults with metastatic melanoma, colorectal cancer, pancreatic ductal adenocarcinoma, or head and neck squamous cell carcinoma harboring MAPK-pathway mutations and no suitable standard options receive oral IPN01194 monotherapy, an ERK1/2 (MAPK1/3) inhibitor targeting the terminal RAS–RAF–MEK–ERK pathway. Dose-escalation identifies two doses, followed by randomized expansion in a single tumor type to assess activity.

ClinicalTrials.gov ID: NCT06305247