Table 3 Clinical trials targeting/relating to the CAF

FAP

68Ga-FAP-2286

-

Phase 1

Metastatic solid cancer

-

-

-

-

NCT04621435

Recruiting

68Ga-FAPI-04

-

Phase 2

Epithelial ovarian cancer

-

-

-

-

NCT04504110

Unknown

-

Phase 1

Various cancer types

-

-

-

-

NCT04459273

Recruiting

[18F] FAPI-74 PET/CT

-

Phase 2

Gastrointestinal cancer

-

-

-

-

NCT05641896

Recruiting

RO6874281

Trastuzumab or cetuximab

Phase 1

BC and HNC

-

-

-

-

NCT02627274

Completed

AVA6000

-

Phase 1

Various solid tumors

-

-

-

-

NCT04969835

Recruiting

Re-directed T cells

-

Phase 1

MPM

-

-

-

-

NCT01722149

Completed

BXCL701

Pembrolizumab

Phase 1Phase 2

Prostate cancer

-

-

-

-

NCT03910660

Active, not recruiting

Pembrolizumab

Phase 2

Metastatic PDAC

-

-

-

-

NCT05558982

Not yet recruiting

CXCR4

AMD3100

Cemiplimab

Phase 2

Metastatic PAC

-

-

-

-

NCT04177810

Completed

BMS-936564

Nivolumab

Phase 1 Phase 2

PAC and SCLC

-

-

-

Serious adverse events: 31/41

Immune-mediated adverse events:4/41

NCT02472977

Terminated

BL-8040

Pembrolizumab

Phase 2

Metastatic PAC

In cohort 1, the DCR was 34.5% in the evaluable population (modified intention to treat, mITT; N = 29), including nine patients (31%) with stable disease and one patient (3.4%) with partial response. In cohort 2, 22 patients received BL-8040 and pembrolizumab with chemotherapy, with an ORR, DCR, and median duration of response of 32%, 77%, and 7.8 months, respectively.

-

3.3 months in cohort 1

A total of 37 patients were enrolled in cohort 1, the most common adverse event was mild to moderate injection site reaction. Only one patient (2.7%) had permanent discontinuation of study drugs owing to treatment-related adverse events (pain and pruritus at the injection site), and no treatment-related deaths were observed

NCT02826486

Completed

Cemiplimab, gemcitabine and nab-paclitaxel

Phase 2

Pancreas adenocarcinoma

-

-

-

-

NCT04543071

Recruiting

MSX-122

-

Phase 1

Refractory metastatic or locally advanced solid tumors

-

-

-

-

NCT00591682

Suspended

POL6326

Eribulin

Phase 1

Metastatic BC

Objective responses (all partial responses) were observed in 16 (30%; 95% CI 18–44) of 54 patients who were evaluable for antitumour activity.

4.6 months (95%CI 3.1–5.7) in the overall efficacy population.

-

The most common treatment-emergent adverse events of any grade were fatigue (44 [79%] of 56 patients), neutropenia (32 [57%]), infusion-related reactions (27 [48%]), alopecia (26 [46%]), constipation (26 [46%]), and nausea (25 [45%]). Serious adverse events occurred in 21 (38%) of 56 patients, including febrile neutropenia in five (9%) of 56 patients, neutrophil count decrease in two (4%) patients, constipation in two (4%) patients, pneumonia in two (4%) patients, and urinary tract infection in three (5%) patients. Two (4%) of 56 patients died while receiving study treatment; one from septic shock and one from pneumonia.

NCT01837095

Completed

TGF-β and PD-L1

M7824

-

Phase 1

Stage II-III HER2 positive breast cancer

-

-

-

-

NCT03620201

Active, not recruiting

SAR439459

Cemiplimab

Phase 1

Malignant solid tumor

-

-

-

-

NCT03192345

Terminated

Cemiplimab

Phase 1

Advanced or unresectable solid tumor

-

-

-

-

NCT04729725

Terminated

TEW-7197

Durvalumab

Phase 2

Urothelial cancer

-

-

-

-

NCT04064190

Not yet recruiting

LY2157299

Nivolumab

Phase 1

Phase 2

Advanced refractory solid tumors, recurrent or refractory NSCLC, or HCC

In phase 2, researchers provide the date on ORR, ORR of galunisertib + nivolumab (NSCLC) group and galunisertib + nivolumab (HCC) group was 24% and 0%

In phase 2, researchers provide the date on mPFS, mPFS of galunisertib + nivolumab (NSCLC) group and galunisertib + nivolumab (HCC) group was 5.62 months and 5.39 months

In phase 2, researchers provide the date on mOS, mOS of galunisertib + nivolumab (NSCLC) group and galunisertib + nivolumab (HCC) group was 11.99 months and 14.52 months

Serious adverse events: 19/41

NCT02423343

Completed

TGF-β

Galunisertib

Paclitaxel

Phase 1

Metastatic androgen receptor negative (AR-) triple negative BC

-

-

-

-

NCT02672475

Active, not recruiting

Fresolimumab

-

Phase 2

Metastatic BC

Abscopal response rate 100% for group: Fresolimumab 1 mg/kg and group; Fresolimumab 10 mg/kg

-

Arm 1: 7.57 months; arm 2: 16.0 months

Serious adverse events 3/11 for group: Fresolimumab 1 mg/kg and 3/12 for Fresolimumab 10 mg/kg

NCT01401062

Completed

LY3200882

Capecitabine

Phase 1

Phase 2

Advanced resistant TGF-beta activated CRC

-

-

-

-

NCT04031872

Unknown

HSP90

XL888

Pembrolizumab

Phase 1

Advanced gastrointestinal cancer

-

-

-

-

NCT03095781

Active, not recruiting

Hedgehog

Sonidegib

Gemcitabine and nab paclitaxel

Phase 1

Phase 2

Pancreatic cancer

 PR 13%, SD 58%, and PD 29%

-

6

six therapy-related grade 4 AEs and three grade 5 were observed

NCT02358161

Completed

Vitamin A

ATRA

Gemcitabine and nab-paclitaxel

Phase 2

Locally advanced PDAC

-

-

-

-

NCT04241276

Recruiting

HDAC, PI3K/AKT

CUDC-907

-

Phase 1

Advanced/relapsed solid tumors

-

-

-

-

NCT02307240

Completed

STAT3

BBI608

Paclitaxel

Phase 3

Non-squamous NSCLC

-

-

-

-

NCT02826161

Terminated

Gemcitabine and nab-paclitaxel

Phase 3

Metastatic PDAC

DCR among napabucasin-treated and control-treated patients was 74.5% and 76.0%, respectively, and ORR was 43.2% and 42.9%, respectively

Napabucasin-treated group: 6.7 months, control-treated   group: 6.1 months

Napabucasin-treated group: 11.4 months, control-treated   group: 11.7 months

The most common AEs among napabucasin-treated and control-treated patients were diarrhoea (73.1% vs 38.9%), nausea (58.6% vs 46.1%), and anaemia (54.5% vs 58.1%). Serious AEs were reported in 58.8% of patients treated with napabucasin plus nab-paclitaxel with gemcitabine and 49.9% of those administered nab-paclitaxel with gemcitabine alone

NCT02993731

Completed

BBI503 or BBI608

Sorafenib

Phase 1 Phase 2

HCC

Researchers provided data on ORR and DCR in phase 2 study. ORR based on RECIST 1.1 criteria among three arms was 3.6% (95%CI 0.1%-18.3%), 0 (95%CI 0-30.8%), 9.7% (95%CI 2%-25.8%), respectively. DCR based on RECIST 1.1 criteria among three arms was 35.7% (95%CI 18.6%-55.9%), 70% (95%CI 34.8%-93.3%), 48.4% (95%CI 30.2%-66.9%), respectively.

-

-

Serious adverse events: 39/91

NCT02279719

Completed

Paclitaxel

Phase 1Phase 2

Advanced malignancies

Researchers provided data on ORR and DCR. ORR among five arms was 0%, 28.4%, 0%, 9.2% and 20.7%, respectively; DCR among five arms was 100%, 53.1%, 0%, 56.1% and 51.7%, respectively

Researchers provided data on mPFS, mPFS among five arms was NA, 2.23 months, NA, 2.07 months and 2.3 months, respectively

Researchers provided data on mOS, mOS among five arms was NA, 7.79 months, NA, 2.07 months and 2.3 months, respectively

Serious adverse events: 53/565

NCT01325441

Completed

LRRC15

ABBV-085

-

Phase1

Advanced solid tumors

In the “all sarcomas at all doses” population the ORR was 10.8%.  In the patients with osteosarcoma or UPS treated at the 3.6 mg/kg dose the ORR was 20%. Among patients with UPS treated at 3.6 mg/kg, four patients had PR with tumor shrinkage of >30%

-

-

Most common treatment-related adverse events were fatigue, nausea, and decreased appetite

NCT02565758

Completed

Hyaluronic acid

PEGPH20

Avelumab

Early Phase 1

Chemotherapy resistant PAC

-

-

-

-

NCT03481920

Terminated

BET

GSK525762

-

Phase 1

NUT midline carcinoma

and other cancers

Among 19 patients with NC, four achieved either confirmed or unconfirmed partial response, eight had stable disease as best response, and four were progression-free for more than 6 months.

Median PFS for the NC cohort was 2.5 months (95% confidence interval = 0.5 to 3.7 months). 

-

The most frequent treatment-related adverse events of any grade were thrombocytopenia (51%) and gastrointestinal events, including nausea, vomiting, diarrhea, decreased appetite, and dysgeusia (22%–42%), anemia (22%), and fatigue (20%).

NCT01587703

Completed

ErbB3

MM-121

-

Phase 1

Advanced solid tumors

ORR was 0%

Median PFS estimate was 7.1 (95% CI: 4.7‒7.4) weeks

in the dose escalation and 7.1 (95% CI: 6.6‒15.9) weeks in the dose expansion portion of the study

-

The most common TEAEs related to seribantumab were nausea (44%), diarrhea (36%), fatigue (28%), and skin rash (24%). No infusion-related reactions or dose-dependency were observed. Serious adverse events (SAEs) occurred in 24% (6/25) of patients in the dose escalation portion

NCT00734305

Completed

HER3

Seribantumab

-

Phase 2

NRG1 gene fusion positive advanced solid tumors

-

-

-

-

NCT04383210

Active, not recruiting

RTKs

Regorafenib

-

Phase 2

 Gastric or gastroesophagel Junction Cancer

-

-

-

-

NCT03627728

Recruiting

Nivolumab

Phase 3

Gastro-oesophageal cancer

-

-

-

-

NCT04879368

Recruiting

-

Gemcitabine

PEGPH20 and placebo

Phase 1

Phase 2

Stage IV Pancreatic Cancer

PEGPH20 1.0 μg/kg group: ORR=0% and DCR=25%

PEGPH20 1.6 μg/kg group: ORR=50% and DCR=100%

PEGPH20 3.0 μg/kg group: ORR=40% and DCR=70%

47 days for group: PEGPH20 1.0 μg/kg

276 days for group: PEGPH20 1.6 μg/kg

113 days for group: PEGPH20 3.0 μg/kg.

109.5 days for group: PEGPH20 1.0 μg/kg

199.5 days for group: PEGPH20 1.6 μg/kg

220 days for group: PEGPH20 3.0 μg/kg

Serious adverse

events were 2/4 for group: PEGPH20 1.0 μg/kg, 1/4 for group: PEGPH20 1.6 μg/kg, and 13/20 for group: PEGPH20 3.0 μg/kg.

NCT01453153

Completed