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Advanced Solid Tumour Trials

A list of our early phase Advanced solid tumour & basket study trials which are open to recruitment at University College London Hospitals

To find more information on UCLH CRF Early Phase Cancer Clinical Trials, including eligibility criteria, click theÌýhyperlinkedÌýLocal Project Reference (LRP)ÌýID, which will take you to the UCLH Find a Study database.

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GO42144

A Phase I/IIa, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD7648 Monotherapy or in Combination with either Cytotoxic Chemotherapies or Novel Anti-Cancer Agents in Patients with Advanced Malignancies

Local Project Reference:
Principal Investigator:Dr. Martin Forster
Drug Class/ Treatment:

AZD7648Ìý(KRAS G12C Inhibitor)

Monotherapy and Combination with Anti-Cancer Therapies

Patient Population:Advanced or Metastatic Solid Tumours with KRAS G12c Mutation
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

IMC-F106C-101

A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

Local Project Reference:
Principal Investigator:Dr. Heather Shaw
Drug Class/ Treatment:IMC-F106C (Bispecific Antibody against HLA-A*02:01)
Patient Population:HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

GARNET

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors.

Local Project Reference:
Principal Investigator:Dr. Rowan Miller
Drug Class/ Treatment:

TSR-042 (Dorstarlimab) (Anti PD-L1 Monoclonal Antibody)

Patient Population:

Advanced Solid Tumours

Cohort F - Patients with Recurrent or Advanced Non-endometrial and non-GI dMMR/MSI-H Solid Tumours orÌýPOLE-Mut Cancers

Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

NX-1607-101

A Phase 1a Dose Escalation Safety and Tolerability Study of NX-1607 a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor in Adults with Advanced Malignancies with Phase 1b Expansion in Select Tumor Types:Ìý A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor, in Adults with Advanced Malignancies, with Phase 1b Expansion in Select Tumor Types

Local Project Reference:
Principal Investigator:Prof. Daniel Hochhauser
Drug Class/ Treatment:NX-1607 -ÌýCBL-B Inhibitor
Patient Population:Advanced Malignancies
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

MODI-1-001

Modi-1 in Patients with Breast, Head & Neck, Ovarian or Renal Cancer: ÌýA Phase 1/2, Multicentre, Open-Label Study of Modi-1 in Patients with Breast, Head and Neck, Ovarian, or Renal Cancer

Local Project Reference:
Principal Investigator:Dr. Rowan Miller
Drug Class/ Treatment:Modi-1 - Novel Cancer Vaccine
Patient Population:

Advanced Solid Tumours:

  • HPV-Negative Squamous Cell Carcinoma of the Head &ÌýNeck (oral cavity, oropharynx, hypopharynx, or larynx).
  • Renal Cell Carcinoma.
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

TAK-676-1002

An Open-label, Dose Escalation, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors

Local Project Reference:
Principal Investigator:Dr Martin Forster
Drug Class/ Treatment:

TAK-676 (Novel Stimulator of Interferon Genes (STING)

Single Agent and in Combination with Pembrolizumab

Patient Population:

Advanced Solid Tumours:

  • Part 2A - Squamous Cell Carcinoma of the Head & Neck (SCCHN)
  • Part 3A - MSI-H/dMMR Colorectal Cancer
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

EP0031-101

A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies

Local Project Reference:
Principal Investigator:Dr Martin Forster
Drug Class/ Treatment:EP0031-101 (Selective RET Inhibitor)
Patient Population:Advanced RET-Altered Malignancies
  • • Cohort 5 - Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC) with RET
  • • Cohort 6 - Locally Advanced or Metastatic Solid Tumours with RET-altered genes
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

Mobilize (mRNA-4359-P101)

Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants with Advanced Solid Tumors

Local Project Reference:
Principal Investigator:Dr Martin Forster
Drug Class/ Treatment:

mRNA-4359-P101 (Checkpoint mRNA cancer vaccine)

Combination with Checkpoint Inhibitors:

  • ·ÌýArm 1b - Combination with Pembrolizumab
Patient Population:

Advanced Solid Tumours:

  • Arm 1b - Melanoma and NSCLC
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

Mobilize (mRNA-4359-P101)

Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants with Advanced Solid Tumors

Local Project Reference:
Principal Investigator:Dr Martin Forster
Drug Class/ Treatment:

mRNA-4349 + Pembrolizumab

Patient Population:

Arm 1 B:

  • Checkpoint Inhibitor Refractgory Melanoma
  • Checkpoint Inhibitor Refracgtory NSCLC
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

GTAEXS617-001

A Phase 1/2 open-label multicenter study to assess the safety, pharmacokinetics, and anti-tumor activity of GTAEXS617 in patients with advanced solid tumors

Local Project Reference:
Principal Investigator:Dr Martin Forster
Drug Class/ Treatment:

GTAEXS617Ìý(Selective CDK7 Inhibitor)

Dose Escalation

Patient Population:

Advanced Solid Tumours

Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

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DETERMINE

An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers with Actionable Genomic Alterations, including Common Cancers with Rare Actionable Alterations

Local Project Reference:
Principal Investigator:Dr Martin Forster
Drug Class/ Treatment:
  • A - Alectinib (ALK Inhibitor)
  • B - Atezolizumab (IgG1 Monoclonal antibody targeting PD-L1)
  • C - Entrectinib (ROS1 & TRK Inhibitor)
  • D - Trastuzumab (HER2 Monoclonal Antibody) + Pertuzumab (HER2 Dimerization Inhibitor)
  • E - Vemurafenib (B-RAF enzyme Inhibitor)
Patient Population:

Adult, Paediatric and Teenage/Young Adult (TYA) Cancers with Actionable Genomic Alterations:

  • A - Adult, Teenage/Young Adults and Paediatric patients with ALK positive cancers.
  • B - Adult, Teenage/Young adults and Paediatric patients with cancers with high tumourÌýÌýÌýÌýÌýÌýÌýÌýÌýÌý mutational burden (TMB) or microsatellite instability-high (MSI-high) or proven constitutional mismatch repair deficiency (CMMRD) disposition.
  • C - Adult, Teenage/Young Adult and Paediatric patients with C-Ros Oncogene 1 (ROS1) geneÌýÌýÌý fusion positive cancers (Not NSCLC).
  • D - Adult, Teenage/Young Adult and Paediatric patients with cancers with HER2 amplification or mutations.
  • E - Adult patients
Trial Hosted By - UCLH Cancer Clinical Trials Unit (CCTU)

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Trials on-hold to recruitment
OVM-200-100
First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine:ÌýÌýA Phase 1, Multicenter, Open-label, Nonrandomized, First-in-human Study of OVM-200 as a Therapeutic Vaccine in Patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer, Ovarian Cancer, and Prostate Cancer
Local Project Reference:
Principal Investigator:Dr. Martin Forster
Drug Class/ Treatment:OVM-200 (Cancer Vaccine)
Patient Population:

Locally Advanced or Metastatic:

Non-Small Cell Lung Cancer
Ovarian Cancer
Prostate Cancer

Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)
GCT1047-01
First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors
Local Project Reference:
Principal Investigator:Dr Michael Flynn
Drug Class/ Treatment:GEN1047Ìý(DuoBody®-CD3×B7H4 Bispecific Antibody)
Patient Population:

Advanced Solid Tumours:

Endometricla Cancer
Platinum-Resistant Ovarian Cancer (PROC)
Triple-Negative Breast Cancer (TNBC)

Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)
XB002-101 (JEWEL-101)
A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Local Project Reference:
Principal Investigator:Dr Michael Flynn
Drug Class/ Treatment:XB002Ìý(Tissue factor (TF)–targeted antibody-drug conjugate)
Patient Population:Advanced Solid Tumours
Trial Hosted By - NIHR UCLH Clinical Research Facility (CRF)

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