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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