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Table 1 Selected trials targeting molecular aberrations enriched in KRAS-wt PDAC

From: KRAS wild-type pancreatic ductal adenocarcinoma: molecular pathology and therapeutic opportunities

Target Tested drug Phase trial Population Primary Outcomes
ALK ceritinib Phase I
NCT02227940
Dose escalation (ALK negative) and expansion cohort (ALK positive) in advanced solid tumors in combination with standard chemotherapy
Expansion cohort 2E: advanced pancreatic cancer ALK positive in combination with gemcitabine and nab-paclitaxel
MTD, RP2D
BRAF binimetinib +
encorafenib
Phase II
NCT04390243
Pancreatic cancer BRAF mutated (V600E) after progression disease to at least one line of chemotherapy ORR
MEK cobimetinib or olaparib trametinib + hydroxychloroquine Early Phase 1
NCT04005690
Phase I
NCT03825289
Diagnosis of pancreatic cancer (resectable, borderline resectable, or advanced) are eligible
Participants may be treatment naive or have received prior therapy
Arm I: cobimetinib
Arm II: Olaparib
Pretreated Advanced Pancreatic Cancer
Assess the feasibility of collecting tumor tissue for biomarker evaluation prior to and after window therapy with either cobimetinib or olaparib
DLT, RP2D
RET selpercatinib
sunitinib
EAP
NCT03906331
Phase IV
NCT02691793
Solid tumors RET activated
RET fusion positive, FGFR2 fusion/FGFR mutation refractory solid tumor
-
PFS
NTRK/ROS1 entrectinib Phase II
NCT02568267
(STARTRK2)
Solid tumors with NTRK1/2/3, ROS1, ALK gene rearrangments ORR
NTRK VDM-928 Phase I
NCT03556228
Expansion phase:
Solid tumors with NTRK1 gene fusions or amplification
AEs
NTRK/ROS1 DS-6051b Phase I
NCT02279433
advanced solid tumors harboring ROS1 or NTRK1, NTRK2, or NTRK3 rearrangement DLT
NRG1 zenocutuzumab
(MCLA-128)
Phase I/II
NCT02912949
Dose escalation (NRG1 negative) and dose expansion (NRG1 positive) in advanced solid tumors
Dose expansion Group G: pancreatic cancer with NRG1 fusion
AEs / SAEs
ORR
DOR
Biomarkers analysis
HER2 A116 Phase I/II
NCT03602079
Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene Phase I: MTD
Phase II: ORR
ACE1702 Phase I
NCT0431975
Advanced or Metastatic HER2-expressing Solid Tumors Safety, DLT, MTD,
RP2D
T-DXd Phase2
NCT04482309
cohort six: patient with no satisfactory alternative treatment option affected by advanced pancreatic cancer with HER2 amplification ORR
afatinib + capecitabine Phase I/IB
NCT02451553
Phase I: pretreated solid tumor
Phase IB: pretreated advanced pancreatic and biliary tract cancer
DLT, MTD,
RP2D
ERK LY3214996 +/− hydroxychloroquine Phase II
NCT04386057
Advanced pancreatic cancer DCR
ulixertinib/Palbociclib Phase I
NCT03454035
Dose escalation cohorts: histologically confirmed advanced refractory solid tumor MTD
Expansion: metastatic pancreatic cancer patients OS
MSI dostarlimab Phase I
NCT02715284
Part 2B: Cohort F non-endometrial dMMR/MSI-H or POLE-Mutated solid tumors, that have progressed following up to 2 prior lines of systemic for advanced disease AE
FGFR pemigatinib Phase II
NCT03822117
Cohort A Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR 1–3 fusion ORR
infigratinib Phase II
NCT04233567
Cohort 1–2: solid tumor harboring FGFR1–3 fusion/translocation who have progressed on or are intolerant to standard of care ORR
erdafitinib Phase II
NCT04083976
Pretreated advanced solid tumor malignancy FGFR mutation or gene fusion ORR
debio 1347 Phase II
NCT03834220
Pretreated Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3 ORR
  1. MTD maximum tolerated dose, RPD2 recommended phase II dose, ORR objective response rate, DLT dose-limiting toxicity, PFS progression free survival, AEs adverse events, SAEs serious adverse events, DOR duration of response, OS overall survival