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Early Phase Cancer Trials Programme at Â鶹´«Ã½ÊÓƵÍøÕ¾ and Â鶹´«Ã½ÊÓƵÍøÕ¾H

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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 Â鶹´«Ã½ÊÓƵÍøÕ¾H CRF Early Phase Cancer Clinical Trials, including eligibility criteria, click theÌýhyperlinkedÌýLocal Project Reference (LRP)ÌýID, which will take you to the Â鶹´«Ã½ÊÓƵÍøÕ¾H Find a Â鶹´«Ã½ÊÓƵÍøÕ¾ database.

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GO42144

A Phase I/IIa, Open-Label Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H Clinical Research Facility (CRF)

IMC-F106C-101

A Phase 1/2 First-in-Human Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H Clinical Research Facility (CRF)

GARNET

A Phase 1 Dose Escalation and Cohort Expansion Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H Clinical Research Facility (CRF)

NX-1607-101

A Phase 1a Dose Escalation Safety and Tolerability Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H 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 Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H Clinical Research Facility (CRF)

TAK-676-1002

An Open-label, Dose Escalation, Phase 1 Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H Clinical Research Facility (CRF)

EP0031-101

A Modular, Open-label, Phase I/II Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H Clinical Research Facility (CRF)

Mobilize (mRNA-4359-P101)

Phase 1/2 Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H Clinical Research Facility (CRF)

Mobilize (mRNA-4359-P101)

Phase 1/2 Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H 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 - Â鶹´«Ã½ÊÓƵÍøÕ¾H Cancer Clinical Trials Unit (CCTU)

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Trials on-hold to recruitment
OVM-200-100
First-in-human Â鶹´«Ã½ÊÓƵÍøÕ¾ of OVM-200 as a Therapeutic Cancer Vaccine:ÌýÌýA Phase 1, Multicenter, Open-label, Nonrandomized, First-in-human Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H Clinical Research Facility (CRF)
XB002-101 (JEWEL-101)
A Dose-Escalation and Expansion Â鶹´«Ã½ÊÓƵÍøÕ¾ 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H Clinical Research Facility (CRF)

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Principal Investigator(s):

Martin Forster Profile
Dr. martin forster

Associate Professor & Consultant Medical Oncologist

Â鶹´«Ã½ÊÓƵÍøÕ¾ ECMC Clinical Lead

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Rowan Miller Profile
dr. rowan miller

Consultant Medical Oncologist

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Dionysis Papadatos-Pastos Profile
dr.ÌýDionysis Papadatos-Pastos

Consultant Medical Oncologist

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Michael Flynn Profile Photo
Dr. michael Flynn

Consultant Medical Oncologist

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Sarah Benafif Profile Photo 200x150
Dr. sarah benafif

Consultant Medical Oncologist

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Heather Shaw Profile Photo
Dr. heather shaw

Consultant Medical Oncologist

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Dr. Elsa Papadimitraki Profile Photo
Dr. Elisavet (Elsa) Papadimitraki

Consultant Medical Oncologist

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Rebecca Roylance Profile
Dr. rebecca roylance

Consultant Medical Oncologist