N=~200
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the J&J Clinical Trial Finder
Key eligibility criteria*:
- Histologically or cytologically confirmed metastatic or unresectable solid tumor of one of the following types:
- RCC-clear cell or papillary carcinoma
- Lung adenocarcinoma
- CRC
- Endometrioid uterine carcinoma
- Endometrioid ovarian cancer
- Measurable or evaluable disease:
- Part 1: either measurable or evaluable disease
- Part 2: ≥1 measurable lesion per RECIST v1.1.
Participants with ovarian cancer without a measurable lesion must have disease evaluable per RECIST v1.1 or have CA125 >2 × ULN during screening
- ECOG PS 0 or 1
- No active CNS involvement
Primary outcomes:
Part 1
- DLTs
Parts 1 and 2
- AEs by severity
Secondary outcomes:
- Serum concentration
- Cmax, Cmin, and Tmax
- AUC[t1-t2] and AUC[0-tau]
- Accumulation ratio
- ADAs
- Objective response rate
- DOR
*Not a complete list of inclusion and exclusion criteria.
Ab, antibody; ADA, anti-drug antibody; AE, adverse event; AUC[0-tau], area under the curve from time 0 to time tau; AUC[t1-t2], area under curve from time t1 to time t2; CA125, cancer antigen 125; CD, cluster of differentiation; Cmax, maximal plasma concentration; Cmin, minimum plasma concentration; CNS, central nervous system; CRC, colorectal cancer; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ENPP3, ectonucleotide pyrophosphatase/phosphodiesterase 3; RCC, renal cell carcinoma; RECIST, Response Evaluation Criteria in Solid Tumors; RP2D, recommended Phase 2 dose; Tmax, time to reach maximal concentration; ULN, upper limit of normal.