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Solid TumorsPhase 1/2NCT04140500

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

A Phase 1/2 study testing RO7247669 in people with Solid Tumors and Metastatic Melanoma, run by Hoffmann-La Roche at 25 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of RO7247669, an anti PD-1 (programmed death-1) and LAG-3 (Lymphocyte-activation gene 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RO7247669
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
25 sitesin 9 countries
Study dates
11 Nov 2019to 30 Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient
  • Eastern Cooperative Oncology Group Performance Status 0-1
  • Fresh biopsies may be required
  • Women of childbearing potential and male participants must agree to remain abstinent or use contraceptive methods as defined by the protocol
  • Additional Specific Inclusion Criteria for Participants with Melanoma
  • Histologically confirmed, unresectable stage III or stage IV melanoma
Show all 19Show fewer
  • Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study
  • Prior treatment with an approved anti-PD-1 or anti-PD-L1 agent
  • Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease
  • Participants with histologically confirmed advanced non-small cell lung cancer
  • Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study
  • Previously treated with approved PD-L1/PD-1 inhibitors
  • Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening
  • Additional Specific Inclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma
  • Participants whose major lesion was histologically confirmed as squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
  • Participants who have previously received not more than 1 prior line of treatment for metastatic disease prior to enrolling in the study
  • Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease
  • Participants with histologically confirmed advanced non-small cell lung cancer
  • Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening

Who cannot join

  • Pregnancy, lactation, or breastfeeding
  • Known hypersensitivity to any of the components of RO7247669
  • Active or untreated central nervous system (CNS) metastases
  • An active second malignancy
  • Evidence of concomitant diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
  • Positive HIV, hepatitis B, or hepatitis C test result
Show all 22Show fewer
  • Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection
  • Vaccination with live vaccines within 28 days prior to Cycle 1 Day 1
  • Treatment with oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
  • Active or history of autoimmune disease or immune deficiency
  • Prior treatment with adoptive cell therapies, such as CAR-T therapies
  • Concurrent therapy with any other investigational drug < 28 days or 5 half-lives of the drug, whichever is shorter, prior to the first RO7247669 administration
  • Regular immunosuppressive therapy
  • Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy
  • Prior treatment with a lymphocyte activation gene-3 (LAG-3) inhibitor
  • Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease
  • Participants with the following muations, rearrangements, translocations are not eligible: EGFR, ALK, ROS1, BRAFV600E, and NTRK
  • Additional Specific Exclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma
  • Prior therapy with any immunomodulatory agents
  • Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease
  • Prior therapy for metastatic disease is not permitted
  • Neo-adjuvant anti-PD-1 or anti-PD-L1 therapy is not allowed

Trial locations and contacts

25 sites in 9 countries.

25 sites in 9 countries

Spain5 sites

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040

  • START Madrid. Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

Turkey (Türkiye)4 sites

  • Adana City Hospital, Medical Oncology

    Adana, 01060

  • Ankara City Hospital

    Ankara, 06800

  • Hacettepe Uni Medical Faculty Hospital

    Sihhiye/Ankara, 06230

  • Ankara Abdurrahman Yurtaslan Oncology Training and Research Hospital Phase 1 Center

    Yen?mahalle, 06200

Other trials in Turkey (Türkiye)

Israel3 sites

  • Hadassah University Hospital - Ein Kerem

    Jerusaelm, 9112001

  • Rabin MC

    Petah Tikva, 4941492

  • Chaim Sheba medical center, Oncology division

    Ramat Gan, 5262000

Other trials in Israel

Mexico3 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

  • Inst. Nacional de Cancerología

    Mexico City, Mexico CITY (federal District), 14080

  • Consultorio Médico Jordi Guzmán Casta

    Querétaro City, Querétaro, 76226

Other trials in Mexico

South Korea3 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Denmark2 sites

  • Rigshospitalet

    København Ø, 2100

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000

Other trials in Denmark

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

United Kingdom2 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Georgia1 site

  • LLC Arensia Explorer Medicine

    Tbilisi, 0112

Other trials in Georgia

About this study

Official title: An Open Label, Multicenter, Dose Escalation, Phase 1 Study to Evaluate Safety/Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti Tumor Activity of RO7247669, a PD1-LAG3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors

This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of RO7247669, an anti PD-1 (programmed death-1) and LAG-3 (Lymphocyte-activation gene 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. This study aims to establish the maximum tolerated dose (MTD) and/or define the recommended phase 2 dose (RP2D) based on the safety, tolerability, pharmacokinetic (PK) and/or pharmacodynamic (PD) profile of RO7247669, and to evaluate preliminary anti-tumor activity in participants with solid tumors. An expansion part of the study is planned to enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RP2D of RO7247669 and to confirm safety and tolerability in participants with selected tumor types.

Being tested
RO7247669
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • RO7247669Drug

    Participants will receive intravenous (IV) RO7247669 at different doses either every 2 weeks (Q2W) or every 3 weeks (Q3W)

Study groups in NCT04140500
Study groupRoleWhat they receive
Part A: Single-Agent Dose EscalationExperimentalParticipants will receive RO7247669 every 2 weeks (Q2W) or every 3 weeks (Q3W) up to the maximum tolerated dose (MTD) until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months.
Receives: Drug: RO7247669
Part B: Tumor Specific Expansion CohortsExperimentalParticipants with selected solid tumor indications will receive RO7247669 at a dose derived from Part A until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months.
Receives: Drug: RO7247669

What is being measured

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

  1. Part A: Percentage of Participants with Dose-Limiting Toxicities (DLTs)

    Measured: Days 1-21 (Q2W dosing) or Days 1-28 (Q3W dosing) of Cycle 1

  2. Part A: Percentage of Participants with Adverse Events

    Measured: Baseline through the end of study (up to 24 months)

  3. Part B: Objective Response Rate (ORR)

    Measured: Up to 24 months

  4. Part B: Disease Control Rate (DCR), Defined as ORR + Stable Disease Rate (SDR)

    Measured: Up to 24 months

  5. Part B: Duration of Response (DOR)

    Measured: Up to 24 months

  6. Part B: Progression-free Survival (PFS), Defined as the Time from the First Study Treatment to the First Occurrence of Progression per Investigator Assessment or Death from any Cause, Whichever Occurs First

    Measured: Up to 24 months

Secondary outcomes (14)

  1. Parts A and B: Maximum Concentration (Cmax) of RO7247669

    Measured: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)

  2. Parts A and B: Time of Maximum Concentration (Tmax) of RO7247669

    Measured: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)

  3. Parts A and B: Clearance (CL) of RO7247669

    Measured: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)

  4. Parts A and B: Volume of Distribution at Steady State (Vss) of RO7247669

    Measured: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)

  5. Parts A and B: Area Under the Curve (AUC) of RO7247669

    Measured: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)

  6. Parts A and B: Half-Life (T1/2) of RO7247669

    Measured: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)

  7. Parts A and B: Percentage of Participants with Anti-Drug Antibodies (ADA) to RO7247669

    Measured: Day 1 of each Cycle, starting with Cycle 1, through final study visit (up to 24 months)

  8. Part B: Change from Baseline in T-Cell Activity

    Measured: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)

  9. Part A: Percentage of Receptors Occupied by RO7247669

    Measured: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)

  10. Part A: ORR

    Measured: At pre-defined intervals from initial dose up to 24 months

  11. Part A: DCR

    Measured: At pre-defined intervals from initial dose up to 24 months

  12. Part A: PFS

    Measured: At pre-defined intervals from initial dose up to 24 months

  13. Part A: DOR

    Measured: At pre-defined intervals from initial dose up to 24 months

  14. Part B: Percentage of Participants with Adverse Events

    Measured: Baseline through the end of study (up to 24 months)

Timeline

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

  1. First posted28 Oct 2019
  2. Study start11 Nov 2019
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04140500
Sponsor's protocol ID
NP41300
Other IDs
2019-000779-18, 2019
Status last verified
Sep 2026
First submitted
24 Oct 2019
Last updated
11 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RO7247669 in people with Solid Tumors and Metastatic Melanoma, run by Hoffmann-La Roche at 25 sites in 9 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 19 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Spain, Turkey (Türkiye), Israel, Mexico, South Korea and 4 more countries. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 A: Percentage of Participants with Dose-Limiting Toxicities (DLTs) (time frame: Days 1-21 (Q2W dosing) or Days 1-28 (Q3W dosing) of Cycle 1). The study lists 6 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 NCT04140500.

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 11 Sep 2026.

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