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Advanced or Metastatic Solid TumorsPhase 1LTbRNCT06448364

A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination

A Phase 1 study testing PF-07329640, sasanlimab and bevacizumab in people with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer, run by Pfizer at 7 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to learn about the safety (the impact of the study drug on the participant's body), effects of the study drug alone or in combination with bevacizumab or sasanlimab, and to find the best dose. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-07329640, sasanlimab and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
7 sitesin 2 countries
Study dates
9 May 2024to 15 Aug 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor
  • Part 1:
  • Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible.
  • Part 1B \& C: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment
  • Part 2:
  • Part 2A:
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  • Cohort 1: Participants with NSCLC must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies.
  • Cohort 2: Participants with MSS CRC must have received at least fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF agent (if not receiving anti-VEGF on protocol), and anti-epidermal growth factor receptor (EGFR) inhibitor (if RAS wildtype) and/or other molecularly targeted therapy if appropriate.
  • Part 2B:
  • NSCLC (2L+) participants as described above in Part 2A
  • MSS CRC (2L+) participants as described above in Part 2A
  • UC (2L+) participants must have received prior platinum-based chemotherapy, anti-PD-(L)1 therapy, or enfortumab vedotin.
  • Part 2C; anti-PDx naive NSCLC (1L) participants must not have received standard of care therapy with anti-PD-(L)1.
  • At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval)
  • Able to provide pre-treatment (and optional on-treatment) tumor tissue
  • Resolution of acute effects of any prior therapy to either baseline or CTCAE Grade 1

Who cannot join

  • Treatment with any systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to planned first dose
  • Prior treatment with another anti-LTβR agonist
  • Systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to planned first dose (6 weeks for mitomycin C or nitrosoureas). Prior targeted or endocrine therapy require an interval of 2 weeks or 5 half-lives (whichever is shorter) prior to planned first dose.
  • Lack of adequate organ (bone marrow, renal, liver) function
  • Active infection requiring systemic treatment.
  • Active or history of autoimmune disease (eg, systemic lupus erythematosus, rheumatoid arthritis) requiring chronic systemic steroid or immune-modulatory therapy (not including oral physiological replacements)
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  • History of Grade ≥3 immune mediated adverse event (AE) (including aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevations that were considered drug related) and/or CRS that was considered related to prior immune-modulatory therapy and required immunosuppressive therapy.
  • Known or suspected hypersensitivity to any PF-07329640 components, or to monoclonal antibodies (mAbs) or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukin, or anti-PD-(L)1 therapy (the latter applicable for Part 1C and Part 2B/C participants only
  • Brain metastasis or primary brain tumor requiring immediate local intervention (surgery, radiosurgery) in the opinion of the investigator.
  • Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, Bowen's disease. Presence of other indolent cancer requires prior sponsor approval.
  • Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant.
  • Pregnant or breastfeeding
  • Persistent or recurring ≥ Grade 2 neuropathy prior to study entry

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States4 sites

  • Highlands Oncology

    Fayetteville, Arkansas, 72703

  • Highlands Oncology

    Rogers, Arkansas, 72758

  • NEXT Oncology

    San Antonio, Texas, 78229

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

Other trials in United States

Puerto Rico3 sites

  • Hospital Oncológico Dr. Isaac González-Martinez

    Rio Piedras, 00935

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935

  • Pan American Center for Oncology Trials- Hospital Oncologico

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: FIRST-IN-HUMAN (FIH), OPEN-LABEL, PHASE 1 DOSE ESCALATION AND EXPANSION STUDY DESIGNED TO EVALUATE THE SAFETY, TOLERABILITY, PK, PD, AND PRELIMINARY CLINICAL ACTIVITY OF PF-07329640 AS A SINGLE AGENT OR IN COMBINATION TREATMENT FOR PARTICIPANTS WITH ADVANCED SOLID TUMORS.

The purpose of this study is to learn about the safety (the impact of the study drug on the participant's body), effects of the study drug alone or in combination with bevacizumab or sasanlimab, and to find the best dose.

This study is seeking participants who have solid tumors that:

Read more
  • have advanced (cancer that doesn't disappear or stay away with treatment) or
  • has spread to other parts of the body (metastatic).

This includes (but limited to) the following cancer types:

  • Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body.
  • Colorectal Cancer (CRC): This is a disease where cells in the colon or rectum grow out of control.
  • Urothelial Cancer (UC): This is a cancer that starts in the urinary systems.
  • Melanoma: Skin cancer that develops when melanocytes (the cells that give the skin its tan or brown color) start to grow out of control.

All participants in this study will receive the study medication (PF-07329640) as an IV infusion (given directly into a vein) at the study clinic every week for repeating 28-day cycles.

Depending on which part of the study participants are enrolled in they will receive the study medication (PF-07329640 alone or in combination with other anti-cancer medications (bevacizumab or sasanlimab). Bevacizumab is given in the clinic as IV infusion every two weeks and sasanlimab is given as a shot under the skin every 4 weeks.

Participants can continue to take the study medication (PF-07329640) and bevacizumab until their cancer is no longer responding. Participants who are taking sasanlimab may receive it for up to 2 years.

The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective.

Participants will be involved in this study for up to 4 years. During this time, they will have a study visit every week. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.

Being tested
PF-07329640, sasanlimab, bevacizumab
Keywords
Solid tumors, metastatic, advanced, micro satellite stable, anti-VEG, anti-PD-1, PF-07329640, LTbetaR, LTbR, sasanlimab, bevacizumab, PD-1 resistance, PD-1 naive, PDx resistance, PDxnaive, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Melanoma, Neoplasm Metastasis, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07329640Biological

    Also called LtbR, LTbetaR

    an anti-lymphotoxin beta receptor agonist

  • sasanlimabBiological

    Also called PF-06801591

    A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2

  • bevacizumabBiological

    Also called Zirabev; Bevacizumab-bvzr

    a monoclonal antibody that blocks VEGF

Study groups in NCT06448364
Study groupRoleWhat they receive
Part 1A: PF-07329640 (αLTβR) MonotherapyExperimentalPF-07329640 (αLTβR) monotherapy at prescribed dose and frequency in 28-day cycles
Receives: Biological: PF-07329640
Part 1B: PF-07329640 (αLTβR) + bevacizumabExperimentalPF-07329640 (αLTβR) + bevacizumab dose escalation in NSCLC and MSS CRC at prescribed dose and frequency in 28-day cycles
Receives: Biological: PF-07329640; Biological: bevacizumab
Part 1C: PF-07329640 (αLTβR) + sasanlimabExperimentalPF-07329640 (αLTβR) + sasanlimab dose escalation in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles
Receives: Biological: PF-07329640; Biological: sasanlimab
Part 2A: PF-07329640 (αLTβR) + bevacizumabExperimentalPF-07329640 (αLTβR) + bevacizumab dose expansion in NSCLC 2L+ and MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles
Receives: Biological: PF-07329640; Biological: bevacizumab
Part 2B: PF-07329640 (αLTβR) + sasanlimabExperimentalPF-07329640 (αLTβR) + sasanlimab dose expansion in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles
Receives: Biological: PF-07329640; Biological: sasanlimab
Part 2C: PF-07329640 (αLTβR) + SOCExperimentalPF-07329640 (αLTβR) + SOC (anti-PD-1+ platinum-based chemo) dose expansion for αPDx-naïve NSCLC 1L at prescribed dose and frequency in 28-day cycles
Receives: Biological: PF-07329640
Part 2D: PF-07329640 (αLTβR)ExperimentalPF-07329640 (αLTβR) dose expansion in advanced solid tumors at prescribed dose and frequency in 28-day cycles
Receives: Biological: PF-07329640

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PART 1: Number of participants with Dose-limiting toxicities (DLT)

    Any of the prespecified AEs that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes:

    Measured: First cycle, Day 1 up to Day 28

  2. PART 1 & 2: Incidence of Adverse Events (AE)s

    An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.

    Measured: From start of the treatment up to 90 days after last dose or start of new anticancer therapy, whichever occurred first

  3. To: PART 1 & 2: Number of participants with laboratory abnormalities

    Number of participants with laboratory test abnormalities. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).

    Measured: From start of treatment up to 90 days after last dose or start of new anticancer therapy, whichever occurred first

  4. Part 2: "Objective Response - Number of Participants With Objective Response "

    Percentage of participants with objective response-based best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator.

    Measured: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'

Secondary outcomes (9)

  1. Part 1: Objective Response - Number of Participants With Objective Response

    Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator

    Measured: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years

  2. Time to event endpoints: duration of response (DOR) by RECIST v1.1

    Time to event: DOR according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by the Investigator.

    Measured: Baseline to confirmed disease progression, up to 2 years after the last dose of study treatmennt

  3. Time to event endpoints: progression-free survival (PFS) by RECIST v1.1

    Time to event: PFS according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by the Investigator.

    Measured: Baseline to confirmed disease progression, up to 2 years after the last dose of study treatmennt

  4. Part 1A: Maximum Observed Serum Concentration (Cmax) of PF-07329640

    Cycle 1: Pre-dose, End of Infusion (EOI), 4, and 8 hours Cycle 2: Pre-dose, EOI, 4, and 8 hours

    Measured: Cycle 1 Day 1 & Cycle 2 Day 1 (each cycle is 28 days)

  5. Part 1A: Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07329640

    Cycle 1: Pre-dose, End of Infusion (EOI), 4, and 8 hours Cycle 2: Pre-dose, EOI, 4, and 8 hours

    Measured: Cycle 1 Day 1 & Cycle 2 Day 1 (each cycle is 28 days)

  6. Part 1A: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07329640

    Cycle 1: Pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 72 hours post-dose (Day 1-4); Pre-dose, EOI, 4 hours post-dose (Day 8); pre-dose, EOI (Day 15) Cycle 2: Pre-dose, EOI, 4, 8, 24, 48, 72 hours post-dose (Day 1-4); Pre-dose, and 4 hours post-dose (Day 15)

    Measured: Cycle 1 Day 1 & Cycle 2 Day 1 (each cycle is 28 days)

  7. Serum Concentrations of PF-07329640 in combination (Part 1B/1C/2A/2B/2C)

    comparison Predose and end of infusion blood serum concentrations at Cycle 1 day 1 and 15, and Cycle Day 1

    Measured: pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1Day 15, Cycle 2 Day 1 (Each cycle is 28 days)

  8. Incidence and titers of antidrug antibodies (ADA) against PF-07329640

    the number of patients with ADAs against PF-07329640 and the concentration of those ADAs

    Measured: Baseline though study completion, an average of 2 years

  9. Paired Tumor Biopsies

    Changes in quantity and maturation state of tertiary lymphoid structure (TLS)s in tumor biopsy tissues at Cycle 2 Day 15

    Measured: Baseline through Cycle 2 Day 15 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2024
  2. Study start9 May 2024
  3. Primary completion15 Aug 2024
  4. Study completion15 Aug 2024

Why it stopped: Strategic business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06448364
Sponsor's protocol ID
C5181001
Acronym
LTbR
Status last verified
Nov 2024
First submitted
17 Apr 2024
Last updated
6 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07329640, sasanlimab and bevacizumab in people with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer, run by Pfizer at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PART 1: Number of participants with Dose-limiting toxicities (DLT) (time frame: First cycle, Day 1 up to Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06448364.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.

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