A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients With PALB2 Mutations
Phase: PHASE2
Conditions: Solid Tumor, Breast Tumor, Colon Tumor, Malignant, Lung Tumor, Urologic Cancer, Pancreatic Cancer, Melanoma, Metastatic Cancer, Locally Advanced Solid Tumor, Esophageal Cancer, Endometrial Cancer, Head and Neck Cancer
Sponsor: Tempus AI

Protocol Clariﬁcation Letter Cover Page 
NCT05169437 
Title: A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid 
Tumor Patients with PALB2 Mutations 
Date: 27July2022 

Tempus TMPS-101 Protocol Clarification Letter  
 
 
 
 
July 27th, 2022 
 
Date: 27-July-2022 
To: PAVO TMPS-101 (218046) Investigational Sites 
Study: A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid 
Tumor Patients with PALB2 Mutations Who Have Received At Least One Line of Prior 
Therapy  
From: 
, MD, Medical Director, Tempus  
Re: Protocol Clarifications 1) Main Criteria for Inclusion #5 2) Main Criteria for Exclusion 
#14 3) Section 1.3, Schedule of Activities Windows 
 
Dear PAVO TMPS-101 Study Investigators and Coordinators: 
This memo is to clarify three items in the protocol: 
(1)  The PAVO TMPS-101 study team is clarifying Main Criteria for Inclusion #5 with the 
following statement in bold:  
Participants must submit fresh or archived (collected within 24 months of enrollment) FFPE 
tumor sample to the central laboratory for post-enrollment confirmation of tPALB2 status, 
where available/clinically feasible and based on sponsor approval. 
 
(2) Exclusion #14, outlining the 3 week pre dose washout period, omitted the term, “definitive”, 
in description of radiation therapy and is updated in bold below (please see section 6.5.1 as well 
for details regarding allowance for palliative RT):   
Participants have received prior systemic cytotoxic chemotherapy, biological therapy, or 
hormonal therapy for cancer, or received definitive radiation therapy within 3 weeks of the first 
dose therapy preceding the study.  
 
(3) Regarding Section 1.3, Schedule of Activities in the study protocol a window for protocol 
required procedures for C1D1 was omitted. It is acceptable for patient laboratory tests noted in 
the Schedule of Activities to be performed within a -1 day window of C1D1. 
 
These clarifications will be added to a future amendment, if one is warranted in the future. Please 
do not hesitate to contact the PAVO TMPS-101 study team with any questions. Thank you very 
much for your continued efforts to make this study a success. 
 
Sincerely, 
 
Medical Director, TEMPUS 
  
Signature:                                                 Date:  7/27/2022