Skip to main content
OpenTrials
Completed

NCT Number: NCT05661578

A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors

The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected solid tumors whose disease is locally advanced, recurrent, or metastatic and for whom an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chongqing Sanxia Central Hospital, Chongqing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy >=12 weeks
  • Adequate hematologic and end organ function
  • Recovery (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia
  • For female participants of childbearing potential, negative serum pregnancy test within 14 days prior to initiation of study treatment (Day 1 of Cycle 1)
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 5 months after the final dose of tiragolumab and atezolizumab IV FDC
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab and atezolizumab IV FDC to avoid exposing the embryo

Cancer-Specific Inclusion Criteria:

  • Histologic documentation of locally advanced, recurrent, or metastatic malignancy, ineligible for definitive local therapy, for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Participant must be informed of all standard of care options available for his/her cancer.
  • No prior treatment with checkpoint inhibitor therapies (CPI-Naive)
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Submittal of archival tumor and/or fresh tumor tissue to the central laboratory for programmed death-1 (PD-L1) evaluation prior to enrollment
  • PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263) immunohistochemistry (IHC) assay

Exclusion criteria

  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of tiragolumab and atezolizumab IV FDC
  • Significant cardiovascular disease
  • Known clinically significant liver disease
  • Poorly controlled Type 2 diabetes mellitus
  • Major surgical procedure within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study
  • Any other diseases, metabolic dysfunction, physical examination finding, and/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 may render the participant at high risk from treatment complications
  • History of autoimmune disease
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
  • History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Severe infections within 4 weeks prior to Day 1 of Cycle 1 or recent infections/oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1

Cancer-Specific Exclusion Criteria:

  • Any anti-cancer therapy, whether investigational or approved within 3 weeks prior to initiation of study treatment
  • Prior treatment with immune checkpoint inhibitors (CPIs)
  • Less than 5 drug-elimination half-lives (~100 days for typical monoclonal antibody [Mab]) from the last dose of monoclonal antibodies (MAbs), and MAb-Derived Therapies (excluding CPIs) and the proposed Day 1 of Cycle 1
  • Less than 6 weeks between the last dose of prior immunomodulators and the proposed Day 1 of Cycle 1
  • Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of prior treatment with cancer vaccines and/or cytokines have elapsed between the last dose and the proposed Cycle 1, Day 1
  • Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy
  • Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred </=6 months prior to Day 1 of Cycle 1
  • Any immune-mediated adverse events related to prior cancer immunotherapy must have resolved completely to baseline
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy

Treatment and study plan

Tiragolumab and Atezolizumab IV FDC

Drug

Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W).

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 30.5 months

    An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.

Secondary outcomes

  1. Area Under the Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Tiragolumab at Cycle 1

    Time frame: Up to Day 21 of Cycle 1 (1 cycle=21 days)

    day*µg/mL=day-micrograms per milliliter.

  2. Area Under the Serum Concentration Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tiragolumab at Cycle 1

    Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)

  3. AUC0-21d of Atezolizumab at Cycle 1

    Time frame: Up to Day 21 of Cycle 1 (1 cycle=21 days)

  4. AUC0-inf of Atezolizumab at Cycle 1

    Time frame: 30 minutes post-dose Day 1 of Cycle 1 (1 cycle=21 days)

  5. Maximum Concentration (Cmax) of Tiragolumab at Cycle 1

    Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)

  6. Cmax of Atezolizumab at Cycle 1

    Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)

  7. Minimum Concentration (Cmin) of Tiragolumab at Cycle 1

    Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)

  8. Cmin of Atezolizumab at Cycle 1

    Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)

  9. Total Body Clearance (CL) of Tiragolumab at Cycle 1

    Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)

  10. CL of Atezolizumab at Cycle 1

    Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)

  11. Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab

    Time frame: Up to approximately 14.9 months

    Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

  12. Number of Participants With ADAs to Atezolizumab

    Time frame: Up to approximately 14.9 months

    Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase II, Single-Arm, Open-Label Study Evaluating the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors

Acronym: SKYSCRAPER-11

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2022
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.