RECRUITING ONCOLOGY TRIALS
Last Updated 19 February 2024 15:00 PM
LOXO-RET-18037 (LIBRETTO)
A Multi-Centre Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumurs with Rearranged During Transfection (RET) Activation
CURRENT SLOT STATUS
On Hold
PHASE
Phase II
REQUIRED MOLECULAR TARGET
RET
TUMOUR TYPES
MTC, NSCLC,
other RET rearranged / mutant
IP CLASS
Targeted
IOS-1002-201
A Phase 1a/1b, first-in-human, open-label, non-randomized, multicenter, dose-escalation and cohort expansion study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of IOS-1002 administered alone and in combination with a PD-1 monoclonal antibody in advanced solid tumors
CURRENT SLOT STATUS
Waitlist
PHASE
Phase Ia/Ib
REQUIRED MOLECULAR TARGET
Not Applicable
TUMOUR TYPES
Solid Tumours
IP CLASS
I-O combination
BGB283/PD901
A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumour Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid tumours
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I
REQUIRED MOLECULAR TARGET
KRAS, NRAS, BRAF
TUMOUR TYPES
NSCLC KRAS, Endometrial KRAS,
LGSOC
IP CLASS
Targeted
BGB-900-105
Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumour Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid tumours
CURRENT SLOT STATUS
On Hold
PHASE
Phase I/II
REQUIRED MOLECULAR TARGET
Not applicable
TUMOUR TYPES
SCCHN PD-L1+ only
IP CLASS
I-O combination
BGB-A317-A3055-101
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
CURRENT SLOT STATUS
Waitlist
PHASE
1a/1b
REQUIRED MOLECULAR TARGET
High CCR8 expressing tumour types (no testing required)
TUMOUR TYPES
HNSCC, NPC, MSI-H/MSS CRC, NSCLC, GEA, TNBC, HER2+ BC, HR+/ HER2- BC, cervical, UC, RCC, ESCC, ovarian, HCC, PDAC & SCLC
IP CLASS
I-O
BGB-A317-30813-101
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I
REQUIRED MOLECULAR TARGET
None
TUMOUR TYPES
Examples include, but are not limited to, NSCLC, HNSCC, SCLC, hepatocellular carcinoma, esophageal, gastric or gastroesophageal carcinoma, nasopharyngeal carcinoma, TNBC, urothelial carcinoma, renal cell carcinoma, cervical, endometrial carcinoma, cutaneous squamous cell carcinoma, melanoma, Merkel cell carcinoma, mesothelioma, MSI-high, TMB-high, or mismatch repair deficient solid tumors
IP CLASS
I-O Combination
THOR 707
An Open-Label, Multicenter Phase 1/2 Dose Escalation and Expansion Study of THOR-707 as a Single Agent and in Combination With a Checkpoint Inhibitor in Adult Subjects With Advanced or Metastatic Solid tumours
CURRENT SLOT STATUS
On Hold
PHASE
Phase I
REQUIRED MOLECULAR TARGET
Not Applicable
TUMOUR TYPES
Solid Tumours
IP CLASS
I-O single/combination
IKS014-01
An open-label, single-arm, Phase 1a/1b study with a 3+3 dose escalation phase, which evaluates FS-1502 (IKS014) in patients with HER2 expressing advanced solid tumors (Phase 1a) followed by an expansion cohort (EC) in HER2+ breast cancer (BCa) (Phase 1b).
CURRENT SLOT STATUS
Waitlist
PHASE
1a
REQUIRED MOLECULAR TARGET
HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untested)
TUMOUR TYPES
Unresectable, HER2+ solid tumours
IP CLASS
Targeted
D1553-101
A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects with Advanced or Metastatic Solid tumours with KRasG12C Mutation
CURRENT SLOT STATUS
On Hold
PHASE
Phase I
REQUIRED MOLECULAR TARGET
KRAS G12C
TUMOUR TYPES
Solid Tumours
IP CLASS
Targeted
Zn-C3-002
A Study of ZN-c3 in Patients With Platinum-Resistant Ovarian Cancer
CURRENT SLOT STATUS
On Hold
PHASE
Phase II
REQUIRED MOLECULAR TARGET
KRAS, NRAS, BRAF
TUMOUR TYPES
Not Applicable
IP CLASS
Targeted with chemo
GO43860
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 Atezolizumab in patients with locally advanced or metastatic solid tumours
CURRENT SLOT STATUS
On Hold
PHASE
Phase I/Ib
REQUIRED MOLECULAR TARGET
Not Applicable
TUMOUR TYPES
Solid Tumours
IP CLASS
I-O combination
NUV-868-01
Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
CURRENT SLOT STATUS
On Hold
PHASE
I/II
REQUIRED MOLECULAR TARGET
BRCA mutation (not required for all cohorts)
TUMOUR TYPES
Ovarian, Pancreatic, mCRPC, TNBC and other solid tumours
IP CLASS
ERAS-254-01
A Study to Assess Naporafenic (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations (SEACRAFT-1).
CURRENT SLOT STATUS
Opening Soon
PHASE
Phase I
REQUIRED MOLECULAR TARGET
RAS Q61X
TUMOUR TYPES
RAS Q61X Solid Tumours
IP CLASS
Targeted
VT3989-001
Phase 1, Multi-Center, Open-Label Study of VT3989 in Patients with
Refractory Locally Advanced or Metastatic Solid Tumors Enriched for
Tumors Harboring Mutations of the Neurofibromatosis Type 2 Gene (mutant
NF2 or mNF2)
CURRENT SLOT STATUS
On Hold
PHASE
Phase I
REQUIRED MOLECULAR TARGET
NF2 mutation
TUMOUR TYPES
Mesothelioma, other solid tumours
IP CLASS
Targeted
GO42144
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid tumours With a KRAS G12C Mutation
CURRENT SLOT STATUS
On Hold
PHASE
Phase I
REQUIRED MOLECULAR TARGET
KRAS G12C
TUMOUR TYPES
Solid Tumours, selected tumour types
IP CLASS
Targeted
BGB-A317-15025-101
A Phase 1 Study Investigating the Safety, Tolerability,
Pharmacokinetics, and Preliminary Antitumor Activity of HPK1
Inhibitor BGB-15025 Alone and in Combination with Anti-PD-1
Monoclonal Antibody Tislelizumab in Patients with Advanced Solid
Tumors
CURRENT SLOT STATUS
On Hold
PHASE
Phase I
REQUIRED MOLECULAR TARGET
Not Applicable
TUMOUR TYPES
Solid tumours, potentially IO sensitive
IP CLASS
I-O combination
GO42273
A phase 1B, open-label, multicenter study to evaluate the safety, pharmacokinetics, and activity of Belvarafenib as a single agent and in combination with either Cobimetinib or Cobimetinib plus Atezolizumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.
CURRENT SLOT STATUS
On Hold
PHASE
Phase I
REQUIRED MOLECULAR TARGET
NRAS
TUMOUR TYPES
Melanoma after IO failure
IP CLASS
Targeted
GSK217228
A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors
CURRENT SLOT STATUS
Waitlist
PHASE
I
REQUIRED MOLECULAR TARGET
Not Applicable
TUMOUR TYPES
IP CLASS
CO42867 (MORPHEUS BREAST)
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC)
CURRENT SLOT STATUS
On Hold
PHASE
Phase I/Ib
REQUIRED MOLECULAR TARGET
ER +ve
TUMOUR TYPES
HR + Breast, prior CDK4/6i
IP CLASS
Targeted
MOST substudy 14
Cancer Molecular Screening and Therapeutics (MoST) Program Substudy Addendum 6 substudy 14-15: Larotrectinib
CURRENT SLOT STATUS
On Hold
PHASE
Phase II
REQUIRED MOLECULAR TARGET
ALK (NGS)
TUMOUR TYPES
Solid tumours, NSCLC (FISH -ve)
IP CLASS
Targeted
MOST substudy 13
A single-arm, open-label, phase II trial of the tumour response to entrectinib in patients with advanced tumours harbouring NTRK fusions or ROS1 gene rearrangements detected by comprehensive genomic profiling
CURRENT SLOT STATUS
On Hold
PHASE
Phase II
REQUIRED MOLECULAR TARGET
ROS-1, NTRK
TUMOUR TYPES
Solid tumours (Incl ASPiRATION)
IP CLASS
Targeted
MOST substudy 12
Single arm, open label, phase II trial of vemurafenib and cobimetinib in patients with advanced tumours harbouring BRAF V600 mutations detected by comprehensive genomic profiling
CURRENT SLOT STATUS
On Hold
PHASE
Phase II
REQUIRED MOLECULAR TARGET
BRAF V600E
TUMOUR TYPES
Solid tumours (not melanoma) (Incl ASPiRATION)
IP CLASS
Targeted
D361DC0001/CAPiTELLO
A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
CURRENT SLOT STATUS
On Hold
PHASE
Phase Ib
REQUIRED MOLECULAR TARGET
HR +ve
TUMOUR TYPES
HR + HER2 - Breast
IP CLASS
Targeted
RLY-4008-101
A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumours
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I
REQUIRED MOLECULAR TARGET
FGFR2
TUMOUR TYPES
Solid Tumours, FGFR2 fusions/mutations/high level CNG
IP CLASS
Targeted
SHR2002-102
A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection in Combination With SHR-1316 in Patients With Advanced Malignant Tumours
CURRENT SLOT STATUS
On Hold
PHASE
Phase I
REQUIRED MOLECULAR TARGET
Not Applicable
TUMOUR TYPES
Solid Tumors
IP CLASS
I-O combination
ELVN-002-001
A Phase 1a/1b Study of ELVN-002 for the Treatment of HER2 mutant or HER2 amplified solid tumors
CURRENT SLOT STATUS
Waitlist
PHASE
Phase Ia/Ib
REQUIRED MOLECULAR TARGET
HER2 mutation
TUMOUR TYPES
NSCLC
IP CLASS
Targeted
MOST substudy 9
Single arm, open label, signal seeking, phase II trial of the activity of tucatinib plus trastuzumab in patients with tumours harbouring HER2 amplifications or mutations
CURRENT SLOT STATUS
On Hold
PHASE
Phase II
REQUIRED MOLECULAR TARGET
HER2 amplification/mutations
TUMOUR TYPES
Solid Tumours
IP CLASS
Targeted
MOST substudy 19
Single arm, open label, signal-seeking phase II study of Sotorasib (AMG-510) in patients with solid tumours harbouring KRAS G12C mutation
CURRENT SLOT STATUS
On Hold
PHASE
Phase II
REQUIRED MOLECULAR TARGET
KRAS G12C,
TUMOUR TYPES
Solid Tumours (not NSCLC, CRC)
IP CLASS
Targeted
D6900C00001
A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants with Advanced or Metastatic Solid Malignancies
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I/IIa
REQUIRED MOLECULAR TARGET
B7-H4 (Central screening using IHC)
TUMOUR TYPES
Advanced or metastatic solid malignancies
IP CLASS
ADC targeting B7-H4
KN-8701
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I
REQUIRED MOLECULAR TARGET
BRAF mutationclass II, III (not BRAFV600E)
TUMOUR TYPES
Solid Tumours
IP CLASS
Targeted
IMP9064-101
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I
REQUIRED MOLECULAR TARGET
ARID1A mutation, multiple other DDR genes
TUMOUR TYPES
Solid Tumours
IP CLASS
Targeted
CLN-619-001
A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors
CURRENT SLOT STATUS
On Hold
PHASE
Phase I
REQUIRED MOLECULAR TARGET
Not Applicable
TUMOUR TYPES
Solid Tumours
IP CLASS
I-O combination
MTX-TROP2-302
CURRENT SLOT STATUS
Waitlist
PHASE
I
REQUIRED MOLECULAR TARGET
N/A
TUMOUR TYPES
Epithelial Tumours
IP CLASS
I-O
BI 1403-0002
A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 in Combination With Ezabenlimab With or Without BI 754111
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I/Ib
REQUIRED MOLECULAR TARGET
MDM2 amplification
TUMOUR TYPES
Solid Tumours
IP CLASS
Targeted I-O combination
PSMA-007-001
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
CURRENT SLOT STATUS
On Hold
PHASE
Phase I
REQUIRED MOLECULAR TARGET
PSMA (imaging)
TUMOUR TYPES
Prostate (Hormone resistant)
IP CLASS
I-O
TYR300-101
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations (SURF301)
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I
REQUIRED MOLECULAR TARGET
FGFR3
TUMOUR TYPES
Solid Tumours
IP CLASS
Targeted
BGB-A317-26808-101
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors
CURRENT SLOT STATUS
Waitlist
PHASE
1a/1b
REQUIRED MOLECULAR TARGET
N/A
TUMOUR TYPES
Solid tumours, potentially IO sensitive
IP CLASS
I-O combination
BGB-A317-30813-101
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
CURRENT SLOT STATUS
On Hold
PHASE
I
REQUIRED MOLECULAR TARGET
N/A
TUMOUR TYPES
Solid tumours
IP CLASS
I-O combination
DB-1311-O-1001
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors
CURRENT SLOT STATUS
Waitlist
PHASE
I/II
REQUIRED MOLECULAR TARGET
N/A
TUMOUR TYPES
IP CLASS
DCSZ11-101
A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCSZ11 as a Monotherapy in Patients with Advanced or Metastatic Solid Tumors
CURRENT SLOT STATUS
Waitlist
PHASE
I
REQUIRED MOLECULAR TARGET
N/A
TUMOUR TYPES
IP CLASS
LOXO-RAS-20001
A Phase 1a/1b Study of LY3537982 in Patients with KRAS
G12C-Mutant Advanced Solid Tumors
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I
REQUIRED MOLECULAR TARGET
KRAS G12C
TUMOUR TYPES
Solid Tumours
IP CLASS
Targeted
AXA-042-FIH-01
A Phase 1a/1b, first-in-human, open-label, non-randomized, multicenter, dose-escalation and
dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of
AXA-042 as monotherapy and in combination with checkpoint inhibitors in subjects with advanced solid
CURRENT SLOT STATUS
Waitlist
PHASE
Phase I
REQUIRED MOLECULAR TARGET
Not Applicable
TUMOUR TYPES
Solid Tumours
IP CLASS
I-O
HMBD-001-102
A Phase 1b study to evaluate HMBD-001 with or without chemotherapy in participants with advanced solid tumours harboring NRG1 fusions.
CURRENT SLOT STATUS
On Hold
PHASE
Phase I b
REQUIRED MOLECULAR TARGET
NRGI Fusion
TUMOUR TYPES
Advanced Solid Tumours
IP CLASS
Targeted/I-O
HMBD-001-103
A Phase 1b study to evaluate HMBD-001 in combination with docetaxel with or without cetuximab in participants with advanced squamous non small cell lung cancer.
CURRENT SLOT STATUS
On Hold
PHASE
Phase Ib
REQUIRED MOLECULAR TARGET
Wild type for MET, KRAS, BRAF, PTEN, PIK3CA
TUMOUR TYPES
Advanced unresectable or metastatic squamous non small cell lung cancer
IP CLASS
Targeted/I-O
DZ2019E0001
Assessing an Oral EGFR Inhibitor, DZD9008 in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
CURRENT SLOT STATUS
On Hold
PHASE
Phase I/II
REQUIRED MOLECULAR TARGET
EGFR exon20ins
TUMOUR TYPES
NSCLC
IP CLASS
Targeted
D3S-002-100
A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy in Adult Subjects with Advanced Solid Tumors with MAPK Pathway Mutations
CURRENT SLOT STATUS
Waitlist
PHASE
I
REQUIRED MOLECULAR TARGET
MAPK Pathway mutation
TUMOUR TYPES
Solid Tumors
IP CLASS
Targeted